Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 1:15 PM
Study NCT ID:
NCT05056766
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apnea-hypopnea index', 'timeFrame': '6 months', 'description': 'severity of sleep apnea'}], 'secondaryOutcomes': [{'measure': 'Epworth Sleepiness Scale score', 'timeFrame': '6 months'}, {'measure': 'pichot fatigue questionnaire', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral appliance'], 'conditions': ['Sleep Apnea Syndromes', 'Sleep Apnea, Obstructive', 'Respiratory Tract Diseases']}, 'descriptionModule': {'briefSummary': 'The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence\n\nOral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).\n\nClinical impact of each mm advancement of Oral Appliance is imperfectly assessed.\n\nThe study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.', 'detailedDescription': 'Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method\n\nPolygraphy and clinical effectiveness of the Oral appliance will be evaluate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients, with primary Moderate sleep apnea or Severe sleep apnea with failure continuous positive airway pressure( CPAP).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Moderate sleep apnea diagnosis with clinical signs\n* Severe sleep apnea with failure continuous positive airway pressure( CPAP)\n\nExclusion Criteria:\n\n* previous sleep apnea treatment for Moderate sleep apnea\n* refusal to participate in research\n* Patient under guardianship, deprived of liberty, safeguard of justice'}, 'identificationModule': {'nctId': 'NCT05056766', 'acronym': 'OAMMM', 'briefTitle': 'How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Valence'}, 'officialTitle': 'How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"', 'orgStudyIdInfo': {'id': 'RIPH-CHV-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single group assignement', 'interventionNames': ['Behavioral: questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.']}], 'interventions': [{'name': 'questionnaires: Epworth Sleepiness Scale; Pichot fatigue questionnaire.', 'type': 'BEHAVIORAL', 'description': 'Each patient will undergo 3 to 7 polygraphy recordings according usual practice of titration At the same time, Self-questionnaires will be conducted by the patient in order to evaluate Oral appliance efficacy.\n\nOptimal titration of oral appliance will be done according subjectives parameters. (sleepeness Reduction and fatigue Reduction).\n\nNeither the investigator nor the patient will know the polygraphy results (apnea-hypopnea index)', 'armGroupLabels': ['single group assignement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26953', 'city': 'Valence', 'country': 'France', 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}], 'overallOfficials': [{'name': 'Guillaume BUIRET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH VALENCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Valence', 'class': 'OTHER'}, 'collaborators': [{'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}