Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-29 @ 8:13 AM
Study NCT ID:
NCT02245659
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2014-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-07', 'releaseDate': '2023-08-03'}], 'estimatedResultsFirstSubmitDate': '2023-08-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], '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': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average nightly hours of CPAP use', 'timeFrame': 'Up to 8 weeks', 'description': 'Calculated over the course of pregnancy, with objective measurement from CPAP device download. CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)'}], 'secondaryOutcomes': [{'measure': 'Recruitment and retention rates in trial', 'timeFrame': 'At completion of study (prior to delivery of baby)'}, {'measure': 'Maternal glucose levels', 'timeFrame': 'Throughout pregnancy until delivery', 'description': 'Continuous glucose monitoring and capillary blood glucose checks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy', 'Sleep-disordered Breathing', 'Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '40183988', 'type': 'DERIVED', 'citation': 'Smocot J, Huynh N, Panyarath P, Kimoff RJ, Meltzer S, Drouin-Gagne L, Newbold R, Hebert C, Benedetti A, Arcache JP, Morency AM, Garfield N, Rey E, Pamidi S. Patterns of adherence to continuous positive airway pressure and mandibular advancement splints in pregnant individuals with sleep-disordered breathing. Sleep Breath. 2025 Apr 4;29(2):148. doi: 10.1007/s11325-025-03284-5.'}, {'pmid': '30505290', 'type': 'DERIVED', 'citation': 'Pamidi S, Meltzer SJ, Garfield N, Lavigne L, Olha A, Khalyfa A, Benedetti A, Tremblay G, Gagnon R, Rey E, Dasgupta K, Kimoff RJ. A Pilot Randomized-Controlled Trial on the Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: Study Design and Methods. Front Endocrinol (Lausanne). 2018 Nov 16;9:659. doi: 10.3389/fendo.2018.00659. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in pregnant patients with sleep-disordered breathing and gestational diabetes', 'detailedDescription': 'Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy, SDB may represent a novel risk factor for GDM, as suggested by recent observational studies. No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet been published.\n\nGeneral Objective: To perform a pilot study to assess the feasibility of conducting a randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the effects of SDB treatment on maternal-fetal outcomes in GDM.\n\nPrimary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM. Secondary Aims: 2) To assess recruitment and retention rates over \\~2 months of treatment 3) To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal glucose levels to determine sample size calculations for a future large-scale multi-site randomized-controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health Centre\n* \\>20 weeks and \\<34 weeks gestational age at time of recruitment\n* Gestational diabetes\n* Sleep-disordered breathing (SDB)\n\nExclusion Criteria:\n\n* Pre-gestational type 1 or type 2 diabetes\n* Multiple pregnancy\n* Conception by IVF\n* Prior treatment for SDB\n* severe medical illness\n* Severe SDB (AHI \\>30) and Epworth Sleepiness Scale \\>15 or oxygen desaturation index \\>30 or sustained hypoxia \\< 80%\n* Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)\n* Cigarette smoking, alcohol consumption or illicit drug use'}, 'identificationModule': {'nctId': 'NCT02245659', 'briefTitle': 'Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial', 'orgStudyIdInfo': {'id': 'RN-326488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP', 'interventionNames': ['Device: CPAP']}, {'type': 'OTHER', 'label': 'Nasal dilator strip', 'description': 'Control', 'interventionNames': ['Other: Nasal dilator strip']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'Continuous Positive Airway Pressure', 'armGroupLabels': ['CPAP']}, {'name': 'Nasal dilator strip', 'type': 'OTHER', 'otherNames': ['Breathe-Right Strip'], 'description': 'Nasal dilator strip to be worn nightly', 'armGroupLabels': ['Nasal dilator strip']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A2Y3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Sushmita Pamidi', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-03', 'type': 'RELEASE'}, {'date': '2024-03-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sushmita Pamidi, Assistant Professor of Medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}