Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 4:23 AM
Study NCT ID:
NCT05939934
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-30', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in subjective sleepiness', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'Sleepiness assessed using the Epworth Sleepiness Scale'}], 'secondaryOutcomes': [{'measure': 'Change in objective sleepiness', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'Osler test'}, {'measure': 'Change in subjective sleep quality', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'Pittsburgh sleep quality index'}, {'measure': 'Change in executive function', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'trail making test'}, {'measure': 'Change in 24 hour blood pressure', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': '24 hours systolic, diastolic and mean blood pressure (Blood pressure holter)'}, {'measure': 'Change in endothelial function', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'endothelial function (assessed by reactive hyperemia arterial tonometry)'}, {'measure': 'Change in cardiac repolarization', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'cardiac repolarization (QTc, TpTec intervals calculation on electrocardiographe))'}, {'measure': 'Change in catecholamines levels', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'urine catecholamines levels'}, {'measure': 'Change in glucose levels', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'blood glucose levels'}, {'measure': 'Change in Microparticles', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'blood microparticles levels'}, {'measure': 'Change in oxydative stress', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'blood 8-isoprostane levels'}, {'measure': 'Change in inflammation', 'timeFrame': 'before and two weeks after CPAP withdrawal', 'description': 'blood CRPus levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.', 'detailedDescription': 'Patients are recruited during sleep consultations in the Angers University Hospital pneumology department among patients followed for severe OSAHS and treated with CPAP. All of the scheduled examinations are carried out in the sleep laboratory of the CHU d\'Angers.\n\nPatients meeting the inclusion criteria and not having any non-inclusion criteria are randomized to the "MAD" group or to the "control" group. For patients in the "MAD" group, an appointment with a stomatologist is organized to make and adjust a thermo-molded type MAD.\n\nAn initial assessment is carried out for all patients during a day hospitalization specific to the study (study of endothelial function, blood pressure, Osler test, ECG, venous and urinary sampling, and completion of the study questionnaires).\n\nPatients are then asked to stop CPAP treatment for two weeks. Patients in the OAM group use OAM during this period. Patients in the control group do not receive any specific treatment for their OSAHS during this period.\n\nAfter 2 weeks of stopping CPAP, a second assessment, identical to the initial assessment, is carried out for all patients. This assessment is carried out during one night of hospitalization which also allows a PSG to be carried out under OAM or without treatment.\n\nAt the end of this assessment, the study is terminated and the patients resume their usual use of CPAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient accepting MAD treatment\n* Patient with an apnea-hypopnea index (AHI) greater than 30 events per hour on the initial recording\n* Patient with excessive daytime sleepiness during initial treatment (ESE\\>10)\n* Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night\n\nExclusion Criteria:\n\n* Initial severe daytime sleepiness characterized\n* OSAS with ≥ 5 central apneas per hour of sleep at baseline recording\n* Previously diagnosed severe cardiac and/or respiratory pathology:\n* Body mass index ≥ 35 kg/m2\n* Known contraindication to OAM treatment'}, 'identificationModule': {'nctId': 'NCT05939934', 'acronym': 'ORTAP', 'briefTitle': 'Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment with Continuous Positive Airway Pressure: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '49RC23_0078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal)'}, {'type': 'EXPERIMENTAL', 'label': 'mandibular advancement device', 'description': 'Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal', 'interventionNames': ['Device: Mandibular advancement device treatment']}], 'interventions': [{'name': 'Mandibular advancement device treatment', 'type': 'DEVICE', 'description': 'a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.', 'armGroupLabels': ['mandibular advancement device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Wojciech Trzepizur, MD Ph D', 'role': 'CONTACT', 'email': 'wotrzepizur@chu-angers.fr', 'phone': '+33680575272'}], 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'wojciech trzepizur, MD PHD', 'role': 'CONTACT', 'email': 'wotrezpizur@chu-angers.fr', 'phone': '+3380575272'}], 'overallOfficials': [{'name': 'wojciech Trzepizur, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Angers University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}