Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 11:30 PM
Study NCT ID:
NCT03858751
Status:
RECRUITING
Last Update Posted:
2022-09-21
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Activation of HMN for OSA Aim 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-06', 'mcpReleaseN': 5, 'releaseDate': '2024-10-15'}], 'estimatedResultsFirstSubmitDate': '2024-10-15'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea hypopnea Index (AHI, average number of events for every hour of sleep)', 'timeFrame': '3 nights (treatment duration)', 'description': 'Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive \\>50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of LTM1201AZ, LTM1201AT, LTM1201AD, LTM1201AG administered before sleep on OSA phenotype traits and OSA severity during sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AHI \\> 10 events/h during NREM supine sleep\n\nExclusion Criteria:\n\n* Any medical condition other than well controlled hypertension and mild diabetes.\n* Any medication known to influence breathing, sleep/arousal, or muscle physiology.\n* Claustrophobia.\n* Inability to sleep supine.\n* Allergy to any of the medications tested in the protocol.\n* History of kidney stones, hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D.\n* Individuals with underlying cardiac disease, such as arrhythmias.\n* Individuals taking psychiatric medications, such as an MAO-I, SSRI or SNRI, or any of the studied medications for medical care.\n* For women: Pregnancy.\n* Pulmonary hypertension\n* Severe OSA with a mean SaO2 lower than 88%'}, 'identificationModule': {'nctId': 'NCT03858751', 'briefTitle': 'Pharmacological Activation of HMN for OSA Aim 2', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Pharmacological Activation of Hypoglossal Motor Nucleus for Obstructive Sleep Apnea Aim 2', 'orgStudyIdInfo': {'id': '2018p001201aim2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsule before bedtime', 'interventionNames': ['Drug: Placebo oral capsule']}, {'type': 'EXPERIMENTAL', 'label': 'LTM1201AZ', 'description': 'LTM1201AZ capsule before bedtime', 'interventionNames': ['Drug: LTM1201AZ']}, {'type': 'EXPERIMENTAL', 'label': 'LTM1201AT', 'description': 'LTM1201AT capsule before bedtime', 'interventionNames': ['Drug: LTM1201AT']}, {'type': 'EXPERIMENTAL', 'label': 'LTM1201AG', 'description': 'LTM1201AG capsule before bedtime', 'interventionNames': ['Drug: LTM1201AG']}, {'type': 'EXPERIMENTAL', 'label': 'LTM1201AD', 'description': 'LTM1201AD capsule before bedtime', 'interventionNames': ['Drug: LTM1201AD']}], 'interventions': [{'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo capsule before bedtime', 'armGroupLabels': ['Placebo']}, {'name': 'LTM1201AZ', 'type': 'DRUG', 'description': 'LTM1201AZ oral capsule before sleep', 'armGroupLabels': ['LTM1201AZ']}, {'name': 'LTM1201AT', 'type': 'DRUG', 'description': 'LTM1201AT oral capsule before sleep', 'armGroupLabels': ['LTM1201AT']}, {'name': 'LTM1201AG', 'type': 'DRUG', 'description': 'LTM1201AG oral capsule before sleep', 'armGroupLabels': ['LTM1201AG']}, {'name': 'LTM1201AD', 'type': 'DRUG', 'description': 'LTM1201AD oral capsule before sleep', 'armGroupLabels': ['LTM1201AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Calianese, Research Assistant', 'role': 'CONTACT', 'email': 'ncalianese@partners.org', 'phone': '617-732-8977'}, {'name': 'Lauren Hess, RPSGT', 'role': 'CONTACT', 'email': 'lhess1@bwh.harvard.edu', 'phone': '617-732-8976'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Scott Aaron Sands', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}