Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-01 @ 12:42 AM
Study NCT ID:
NCT04279834
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2020-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Outcomes for Patients With SDB and Insufficient Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000077260', 'term': 'Sleepiness'}], 'ancestors': [{'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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': '3-months after randomization', 'description': 'ESS is an 8-item questionnaire that assesses general level of daytime sleepiness. Total score ranges from 0 - 24, with higher scores indicating greater sleepiness.'}], 'secondaryOutcomes': [{'measure': 'Reactive hyperemia index', 'timeFrame': '3-months after randomization', 'description': 'Endothelial function will be measured by peripheral arterial tonometry (PAT) collected by fingertip sensor. Proprietary software is used to calculate a reactive hyperemia index.'}, {'measure': '24-hours Ambulatory Blood Pressure', 'timeFrame': '3-months after randomization', 'description': 'Blood pressure will be monitored over a 24-hour period. Mean 24-hour blood pressure, mean daytime (rise time - bed time), and mean nocturnal (bed time - rise time) blood pressure will be calculated.'}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': '3-months after randomization', 'description': "The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a point scale of 1 to 7 from strongly disagree to strongly agree. The minimum possible score is 9 and highest score is 63. A higher score indicates more severe fatigue and impact on the person's activities."}, {'measure': 'Psychomotor Vigilance Test (PVT)', 'timeFrame': '3-months after randomization', 'description': 'PVT is a performance measure of alertness and vigilance. Reaction time to a visual cue, delivered at random intervals varying from 2 to 10 seconds, is measured. The total number of lapses (reaction time \\>500ms) during the 10 minute test will be used as a measure of objective alertness.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleepiness', 'Hypertension', 'Sleep', 'Sleep Apnea', 'Endothelial Function', 'Alertness', 'Behavioral Intervention'], 'conditions': ['Sleep Apnea', 'Insufficient Sleep Syndrome', 'Sleep', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness.\n\nIn this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.', 'detailedDescription': 'Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB.\n\nThis study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.\n\nBoth groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.\n\nMain study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for enrollment are:\n\n* Over age 18 years\n* Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)\n\nAdditional Inclusion Criteria for randomization will be:\n\n* ESS score \\>6\n* Total sleep time \\<7 hours at least 4 nights per week, based on baseline sleep diary.\n\nExclusion Criteria:\n\n* Current use of PAP or oral appliance therapy for SDB\n* Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)\n* A recent health event that may affect sleep (e.g. recent surgery or hospitalization)\n* Current alcohol or substance use disorder (\\<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis)\n* Pregnancy or within 6 months post-partum\n* Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS\\>18\n* Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and\n* Central sleep apnea (defined as central apnea/hypopnea index \\>5, and \\>50% of total AHI).\n* Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range.'}, 'identificationModule': {'nctId': 'NCT04279834', 'acronym': 'RESTORE', 'briefTitle': 'Improving Outcomes for Patients With SDB and Insufficient Sleep', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Improving Outcomes for Patients With SDB and Insufficient Sleep', 'orgStudyIdInfo': {'id': '1809001759'}, 'secondaryIdInfos': [{'id': 'R01HL146059', 'link': 'https://reporter.nih.gov/quickSearch/R01HL146059', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PAP Treatment', 'description': 'Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.', 'interventionNames': ['Behavioral: PAP Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Education I', 'description': 'Participants will attend four weekly sessions to receive education about strategies to improve sleep.', 'interventionNames': ['Behavioral: Sleep Education I']}], 'interventions': [{'name': 'PAP Treatment', 'type': 'BEHAVIORAL', 'description': 'Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.', 'armGroupLabels': ['PAP Treatment']}, {'name': 'Sleep Education I', 'type': 'BEHAVIORAL', 'description': 'Motivational enhancement plus participant self-monitoring of sleep.', 'armGroupLabels': ['Sleep Education I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'M. Safwan Badr, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Safwan Badr', 'investigatorAffiliation': 'Wayne State University'}}}}