Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT02112435
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2014-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal', 'United States']}, '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': 'D017090', 'term': 'Occlusal Splints'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2014-04-05', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'following 3 months of treatment', 'description': 'Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI \\<15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night'}], 'secondaryOutcomes': [{'measure': 'Rate of Complete Response', 'timeFrame': 'following 3 months of treatment', 'description': 'Rate of Complete Response (TRc) =% Patients with AHI \\<15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night)'}, {'measure': 'Partial response rate', 'timeFrame': 'Following 3 months of treatment', 'description': 'Partial response rate =% of patients with reduction AHI ≥ 50% with AHI\\> 15 or AHI \\<15 with reduction \\<50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.'}, {'measure': 'Subjective compliance', 'timeFrame': 'Following 3 months of treatment', 'description': 'Subjective compliance'}, {'measure': 'Sleep quality', 'timeFrame': 'Following 3 months of treatment', 'description': 'sleep efficiency, total sleep time'}, {'measure': 'Desaturation', 'timeFrame': 'Following 3 months of treatment', 'description': 'desaturation index, time spent below 90%'}, {'measure': 'Subjective sleep', 'timeFrame': 'Following 3 months of treatment', 'description': 'Pittsburgh questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'Following 3 months of treatment', 'description': 'Functional outcomes sleep questionnaire (FOSQ)'}, {'measure': 'Fatigue', 'timeFrame': 'Following 3 months of treatment', 'description': 'Chalder fatigue questionnaire'}, {'measure': 'Subjective daytime sleepiness', 'timeFrame': 'Following 3 months of treatment', 'description': 'Epworth sleepiness score'}, {'measure': 'Side effects', 'timeFrame': 'Following 3 months of treatment', 'description': 'side effects and interactions with the dental evaluations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'mandibular advancement splint', 'active mandibular advancement splint', 'oral appliance'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 65 years\n* severe OSA confirmed by polysomnography (PSG) is: 30\\> AHI\\> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI\\> 30\n* patient in failure or refusal of CPAP treatment\n* agree to participate and sign the consent form research\n* speak and understand French without external assistance\n* be in good health (no neurological or psychiatric syndrome).\n* have a valid Social Security card (in France and Portugal only)\n\nExclusion Criteria:\n\n* contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion\n* dental restorations in progress or planned in the next 6 months\n* psychiatric and neuromuscular disorders\n* untreated cardiovascular diseases and history of stroke or myocardial infarction\n* severe or morbid obesity (body mass index\\> 35)'}, 'identificationModule': {'nctId': 'NCT02112435', 'acronym': 'SOMNYX', 'briefTitle': 'Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '14-011-CERES-D'}, 'secondaryIdInfos': [{'id': 'NH-14SRP-Somnyx', 'type': 'OTHER', 'domain': 'Faculté de medecine dentaire, Université de Montreal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Narval ORM ® or SomnoDent ®', 'description': 'Mandibular advancement splint (Narval ORM ® or SomnoDent ®)', 'interventionNames': ['Device: Narval ORM ® or SomnoDent ®']}, {'type': 'EXPERIMENTAL', 'label': 'Somnyx ®', 'description': 'Active mandibular advancement splint (Somnyx ®)', 'interventionNames': ['Device: Somnyx ®']}], 'interventions': [{'name': 'Somnyx ®', 'type': 'DEVICE', 'otherNames': ['Active mandibular advancement appliance', 'Oral appliance'], 'description': 'Active mandibular advancement splint', 'armGroupLabels': ['Somnyx ®']}, {'name': 'Narval ORM ® or SomnoDent ®', 'type': 'DEVICE', 'otherNames': ['Mandibular advancement splint', 'Mandibular advancement appliance', 'Oral appliance', 'Mandibular repositioning appliance', 'Mandibular repositioning splint'], 'description': 'Mandibular advancement splint', 'armGroupLabels': ['Narval ORM ® or SomnoDent ®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3C3J7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Université Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nelly Huynh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant research professor', 'investigatorFullName': 'Nelly Huynh', 'investigatorAffiliation': 'Université de Montréal'}}}}