Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 3:57 AM
Study NCT ID:
NCT04639193
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2020-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}, {'id': 'D000069582', 'term': 'Eszopiclone'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cschmickl@health.ucsd.edu', 'phone': '8582462154', 'title': 'Dr Chris Schmickl', 'organization': 'University of California San Diego'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the trial subjects were asked at each visit whether any adverse events had occurred during that 3-day study phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bad Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cloudy Urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Taste when Drinking Carbonated Beverages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metallic Taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnea Hypopnea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'title': 'AHI (supine, NREM)', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '37.7'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '51.8'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '40'}]}]}, {'title': 'AHI (overall)', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '38.3'}, {'value': '37.4', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '50'}, {'value': '25.8', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '43.3'}]}]}, {'title': 'AHI4 (overall)', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '27.3'}, {'value': '20.3', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '37.9'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '14.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \\>=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other studies, we also explored the AASM-acceptable "AHI4", which defines hypopneas as reduced breathing for 10+ seconds associated with a \\>=4% desaturation.', 'unitOfMeasure': 'events/hour of sleep', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SpO2 Nadir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG000', 'lowerLimit': '79.8', 'upperLimit': '87.2'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '85.2'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '82.5', 'upperLimit': '87.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'The lowest measured blood oxygen saturation during the overnight sleep study measured in percent.', 'unitOfMeasure': 'Percent Oxygen Saturation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'title': 'Vpasssive, transformed', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '78.2'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '59.4', 'upperLimit': '73.2'}, {'value': '70.4', 'groupId': 'OG002', 'lowerLimit': '61.7', 'upperLimit': '75.3'}]}]}, {'title': 'Vactive', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '99.1'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '97.7'}, {'value': '94.4', 'groupId': 'OG002', 'lowerLimit': '83.9', 'upperLimit': '99.6'}]}]}, {'title': 'Arousal Threshold, transformed', 'categories': [{'measurements': [{'value': '140.1', 'groupId': 'OG000', 'lowerLimit': '126.7', 'upperLimit': '161.5'}, {'value': '149.8', 'groupId': 'OG001', 'lowerLimit': '137.9', 'upperLimit': '162.2'}, {'value': '137.2', 'groupId': 'OG002', 'lowerLimit': '125', 'upperLimit': '155.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Pathophysiological traits were quantified as %Veupnea from polysomnography data using a validated algorithm.', 'unitOfMeasure': '% Veupnea', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pathophysiological Trait: Loop Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.59'}, {'value': '0.57', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '0.69'}, {'value': '0.49', 'groupId': 'OG002', 'lowerLimit': '0.44', 'upperLimit': '0.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Loop Gain 1 was quantified from polysomnography data using a validated algorithm. This metric measures the increase in respiratory drive relative to a preceding drop in ventilation and thus is dimensionless (typical range is approximately 0.2 to 1.5, with values \\>0.7 being considered high loop gain, indicating ventilatory instability)', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'title': 'Based on AHI in supine NREM sleep', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Based on AHI overall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 nights', 'description': 'Full responders were defined as a drop in AHI\\>50% to \\<10/h.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '112.5', 'groupId': 'OG000', 'lowerLimit': '107.8', 'upperLimit': '119.8'}, {'value': '116.5', 'groupId': 'OG001', 'lowerLimit': '109.8', 'upperLimit': '124.5'}, {'value': '116', 'groupId': 'OG002', 'lowerLimit': '110.2', 'upperLimit': '120.8'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '67.8', 'upperLimit': '78.2'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '82'}, {'value': '70.5', 'groupId': 'OG002', 'lowerLimit': '63.2', 'upperLimit': '79.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Systolic/Diastolic Blood Pressure (measured at rest in the morning following the overnight sleep study).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Sleepiness: Stanford Sleepiness Scale (SSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Subjective sleepiness was assessed using the Stanford Sleepiness Scale (SSS) in the morning following the overnight sleep study. The score ranges from 1 to 7, with greater values indicating more sleepiness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '56.3'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '49.9', 'upperLimit': '57.8'}, {'value': '53', 'groupId': 'OG002', 'lowerLimit': '48.8', 'upperLimit': '55.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Sleep quality was assessed based on a modified 8-question PROMIS Sleep Disturbance (SDA 8b) questionnaire in the morning following the overnight sleep study. The raw score ranges from 8 to 40 and is translated into a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Greater T-scores indicate greater sleep disturbance.', 'unitOfMeasure': 't-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psychomotor Vigilance: Response Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '3.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.4'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '3.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \\>500ms).', 'unitOfMeasure': '1/seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Psychomotor Vigilance: Lapses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dual-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.'}, {'id': 'OG002', 'title': 'Triple-Therapy', 'description': '* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8.2'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6.2'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '9.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 nights', 'description': 'Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \\>500ms).', 'unitOfMeasure': 'Number of lapses', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo, Then Dual-Therapy, Then Triple-Therapy', 'description': 'Subjects started with a 3-day PLACEBO regimen:\n\n* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects then crossed over to a 3-day EXPERIMENTAL DUAL-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects then underwent an OPEN-LABEL TRIPLE-regimen:\n\nDay 1: Acetazolamide 250mg at bedtime at home. Day 2: Acetazolamide 500mg at bedtime at home. Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory\n\nAcetazolamide: Acetazolamide tablet (encapsulated) Eszopiclone: Eszopiclone tablet (encapsulated) Placebo: Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone Venlafaxine: Venlafaxine capsule'}, {'id': 'FG001', 'title': 'Dual-Therapy, Then Placebo, Then Triple-Therapy', 'description': 'Subjects started with a 3-day EXPERIMENTAL DUAL-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects then crossed over to a 3-day PLACEBO regimen:\n\n* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects then underwent an OPEN-LABEL TRIPLE-regimen:\n\nDay 1: Acetazolamide 250mg at bedtime at home. Day 2: Acetazolamide 500mg at bedtime at home. Day 3: Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory\n\nAcetazolamide: Acetazolamide tablet (encapsulated) Eszopiclone: Eszopiclone tablet (encapsulated) Placebo: Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone Venlafaxine: Venlafaxine capsule'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 88 subjects who were assessed for eligibility, 20 were randomized. The other 68 were excluded due to not meeting eligibility criteria or not being interested.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants Who Were Enrolled Into the Trial', 'description': 'All 20 participants who were randomized, completed the dual-therapy and placebo phases (blinded/random order) 18 of these 20 participants went on to also complete the the open label triple therapy phase'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'groupId': 'BG000', 'lowerLimit': '27.6', 'upperLimit': '34.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Apnea Hypopnea Index (AHI)', 'classes': [{'title': 'AHI (supine, NREM)', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '48.8'}]}]}, {'title': 'AHI (overall)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'BG000', 'lowerLimit': '21.5', 'upperLimit': '50.7'}]}]}, {'title': 'AHI4 (overall)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'BG000', 'lowerLimit': '10.8', 'upperLimit': '29.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'The AHI is a measure of sleep apnea severity and is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \\>=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. The "AHI4" defines hypopneas as reduced breathing for 10+ seconds associated with a \\>=4% desaturation.', 'unitOfMeasure': 'events/hour of sleep', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold', 'classes': [{'title': 'Vpasssive, transformed', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'BG000', 'lowerLimit': '61.1', 'upperLimit': '73'}]}]}, {'title': 'Vactive', 'categories': [{'measurements': [{'value': '92.1', 'groupId': 'BG000', 'lowerLimit': '79.2', 'upperLimit': '97.9'}]}]}, {'title': 'Arousal Threshold, transformed', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000', 'lowerLimit': '127.7', 'upperLimit': '156.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Pathophysiological traits were quantified as %Veupnea from polysomnography data using a validated algorithm.', 'unitOfMeasure': '% Veupnea', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pathophysiological Trait: Loop Gain', 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'BG000', 'lowerLimit': '0.50', 'upperLimit': '0.65'}]}]}], 'paramType': 'MEDIAN', 'description': 'Loop Gain 1 was quantified from polysomnography data using a validated algorithm. This metric measures the increase in respiratory drive relative to a preceding drop in ventilation and thus is dimensionless (typical range is approximately 0.2 to 1.5, with values \\>0.7 being considered high loop gain, indicating ventilatory instability).', 'unitOfMeasure': 'dimensionless', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-17', 'size': 523170, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-26T12:56', 'hasProtocol': True}, {'date': '2021-08-17', 'size': 340345, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-26T12:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled, cross-over trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2020-11-12', 'resultsFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-08', 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index (AHI)', 'timeFrame': '3 nights', 'description': 'The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a \\>=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other studies, we also explored the AASM-acceptable "AHI4", which defines hypopneas as reduced breathing for 10+ seconds associated with a \\>=4% desaturation.'}], 'secondaryOutcomes': [{'measure': 'SpO2 Nadir', 'timeFrame': '3 nights', 'description': 'The lowest measured blood oxygen saturation during the overnight sleep study measured in percent.'}, {'measure': 'Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold', 'timeFrame': '3 nights', 'description': 'Pathophysiological traits were quantified as %Veupnea from polysomnography data using a validated algorithm.'}, {'measure': 'Pathophysiological Trait: Loop Gain', 'timeFrame': '3 nights', 'description': 'Loop Gain 1 was quantified from polysomnography data using a validated algorithm. This metric measures the increase in respiratory drive relative to a preceding drop in ventilation and thus is dimensionless (typical range is approximately 0.2 to 1.5, with values \\>0.7 being considered high loop gain, indicating ventilatory instability)'}, {'measure': 'Percent Responders', 'timeFrame': '3 nights', 'description': 'Full responders were defined as a drop in AHI\\>50% to \\<10/h.'}, {'measure': 'Blood Pressure', 'timeFrame': '3 nights', 'description': 'Systolic/Diastolic Blood Pressure (measured at rest in the morning following the overnight sleep study).'}, {'measure': 'Subjective Sleepiness: Stanford Sleepiness Scale (SSS)', 'timeFrame': '3 nights', 'description': 'Subjective sleepiness was assessed using the Stanford Sleepiness Scale (SSS) in the morning following the overnight sleep study. The score ranges from 1 to 7, with greater values indicating more sleepiness.'}, {'measure': 'Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance', 'timeFrame': '3 nights', 'description': 'Sleep quality was assessed based on a modified 8-question PROMIS Sleep Disturbance (SDA 8b) questionnaire in the morning following the overnight sleep study. The raw score ranges from 8 to 40 and is translated into a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Greater T-scores indicate greater sleep disturbance.'}, {'measure': 'Psychomotor Vigilance: Response Speed', 'timeFrame': '3 nights', 'description': 'Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \\>500ms).'}, {'measure': 'Psychomotor Vigilance: Lapses', 'timeFrame': '3 nights', 'description': 'Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time \\>500ms).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'drug'], 'conditions': ['OSA', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '39514000', 'type': 'DERIVED', 'citation': 'Schmickl CN, Orr JE, Alex RM, Gruenberg E, Parra G, White S, Spenceley A, DeSarkar T, Kong M, DeYoung PN, Sands SA, Owens RL, Malhotra A. Combination Drug Therapy with Acetazolamide, Eszopiclone +/- Venlafaxine for Obstructive Sleep Apnea (RESCUE-Combo): A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Ann Am Thorac Soc. 2025 Feb;22(2):263-273. doi: 10.1513/AnnalsATS.202407-736OC.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox \\[acetazolamide\\], Lunesta \\[eszopiclone\\] +/- Effexor \\[venlafaxine\\]) on OSA severity and physiology.', 'detailedDescription': 'Study participants will undergo three 3-day drug regimens. On days 1 and 2 of each drug regimen, subjects will take the study drugs at home; on day 3 of each drug regimen subjects will take the study drugs as part of an overnight inlab sleep study (including assessments of sleepiness/alertness, sleep quality and blood pressure). Initially subjects will take dual-therapy (acetazolamide+eszopiclone) vs placebo in random order; if sleep apnea resolved with dual-therapy, then subjects will undergo an open-label single-drug regimen (acetazolamide), else an open-label triple-drug regimen (acetazolamide + eszopiclone + venlafaxine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-40 kg/m2\n* Untreated Moderate or Severe OSA (AHI during supine NREM sleep \\>15/h) with a fraction of hypopneas \\>25% of all events\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Prisoners\n* Adherent with effective therapy for OSA\n* Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy\n* Inability to sleep supine for overnight sleep studies\n* Circadian rhythm disorder\n* Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure\n* Uncontrolled hypertension (systolic blood pressure \\>160mmHg, diastolic blood pressure \\>95mmHg)\n* Presence of tracheostomy\n* Hospitalization within the past 90 days\n* Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\\< 5 years)\n* Prior gastric bypass surgery\n* Chronic liver disease or end-stage kidney disease\n* Active illicit substance use or \\>2 oz daily alcohol use (i.e. \\>2 12 oz bottles of beers, \\>2 5 oz glasses of wine, \\>2 1.5 oz glasses of hard liquor such as spirits, gin, whiskey, etc.)\n* Psychiatric disease, other than well controlled depression/anxiety\n* Cognitive impairment, inability to provide consent, or inability to complete research procedures (e.g. questionnaires that are only available/validated in English)\n* Chronically using study drugs or drugs with similar pharmacodynamic effects (acetazolamide - carbonic anhydrase inhibitors, eszopiclone - benzodiazepine receptor agonists, venlafaxine - serotonin/norepinephrine reuptake inhibitors and other antidepressants)\n* Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)\n* Contraindications to taking study drugs, including allergies to any of the drugs or sulfa allergy; concomitant use of antidepressants, opioids, sedatives/hypnotics, thiazide diuretics or angiotensin-receptor blockers; or severe nocturnal hypoxia (SpO2 nadir \\<70% on diagnostic sleep study).'}, 'identificationModule': {'nctId': 'NCT04639193', 'acronym': 'RESCUE-Combo', 'briefTitle': 'Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Rescuing OSA Patients Unable to Tolerate CPAP Using Endotype-Targeted Combination Drug Therapy: a Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '191990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo, then Dual-Therapy, then Single/Triple-Therapy', 'description': 'Subjects will start with a 3-day PLACEBO regimen:\n\n* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects will then cross-over to a 3-day EXPERIMENTAL DUAL-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively.', 'interventionNames': ['Drug: Acetazolamide', 'Drug: Eszopiclone', 'Drug: Placebo', 'Drug: Venlafaxine']}, {'type': 'EXPERIMENTAL', 'label': 'Dual-Therapy, then Placebo, then Single/Triple-Therapy', 'description': 'Subjects will start with a 3-day EXPERIMENTAL DUAL-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects will then cross-over to a 3-day PLACEBO regimen:\n\n* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.\n* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.\n* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.\n\nAfter a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:\n\n* Day 1: Acetazolamide 250mg at bedtime at home.\n* Day 2: Acetazolamide 500mg at bedtime at home.\n* Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively.', 'interventionNames': ['Drug: Acetazolamide', 'Drug: Eszopiclone', 'Drug: Placebo', 'Drug: Venlafaxine']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Acetazolamide tablet (encapsulated)', 'armGroupLabels': ['Dual-Therapy, then Placebo, then Single/Triple-Therapy', 'Placebo, then Dual-Therapy, then Single/Triple-Therapy']}, {'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'description': 'Eszopiclone tablet (encapsulated)', 'armGroupLabels': ['Dual-Therapy, then Placebo, then Single/Triple-Therapy', 'Placebo, then Dual-Therapy, then Single/Triple-Therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone', 'armGroupLabels': ['Dual-Therapy, then Placebo, then Single/Triple-Therapy', 'Placebo, then Dual-Therapy, then Single/Triple-Therapy']}, {'name': 'Venlafaxine', 'type': 'DRUG', 'otherNames': ['Effexor'], 'description': 'Venlafaxine capsule', 'armGroupLabels': ['Dual-Therapy, then Placebo, then Single/Triple-Therapy', 'Placebo, then Dual-Therapy, then Single/Triple-Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical and Translational Research Institute Building', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92121', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Health - Pulmonary and Sleep Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Christopher Schmickl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Physician and Postdoctoral Fellow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Thoracic Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christopher Schmickl', 'investigatorAffiliation': 'University of California, San Diego'}}}}