Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT06568159
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-07-26', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with MAD and CPAP at 6 months (wearing time).', 'timeFrame': '6 months post-inclusion', 'description': 'MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit.\n\nCPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary).'}], 'secondaryOutcomes': [{'measure': 'Assessment of oral status', 'timeFrame': 'the day of inclusion', 'description': 'plaque index : values from 0 to 3. A high score is a worse outcome.'}, {'measure': 'Assessment of oral status', 'timeFrame': 'the day of inclusion', 'description': 'mobility index : values from 1 to 4. A high score is a worse outcome.'}, {'measure': 'Assessment of oral status', 'timeFrame': 'the day of inclusion', 'description': 'bleeding index : values from 0 to 1 (100%). A high score is a worse outcome.'}, {'measure': 'Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)', 'timeFrame': '6 months post-inclusion', 'description': 'survey : values from 0 to 3. A high score is a better outcome.'}, {'measure': 'Clinical parameters of OSA (objective)', 'timeFrame': '6 months post-inclusion', 'description': 'ventilatory polygraphy or polysomnography'}, {'measure': 'Assessment of quality of life', 'timeFrame': '6 months post-inclusion', 'description': 'Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good.'}, {'measure': 'Clinical parameters of OSA (subjective)', 'timeFrame': '6 months post-inclusion', 'description': 'Survey. Values : light, moderate, significant'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Coronary Disease', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases.\n\nContinuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI\\>30) OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTarget population: with coronary artery disease or at very high risk of coronary artery disease:\n\n* Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.).\n* Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria)\n* Diabetic patients at high cardiovascular risk\n* Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD.\n\nFor the control group (CPAP): patients with moderate or severe OSA treated with CPAP.\n\nExclusion Criteria:\n\n* Patients with heart failure not stabilised according to the investigator (NYHA IV)\n* Severe psychiatric disorders\n* Pregnant or breast-feeding women\n* Opposition to participation after a period of reflection\n* Not affiliated to a social security scheme,\n* Persons under court protection,\n* Persons under guardianship or curatorship\n* Person taking part in another study with an exclusion period still in progress\n* Inability to follow the patient during the study period.'}, 'identificationModule': {'nctId': 'NCT06568159', 'acronym': 'PACOAM', 'briefTitle': 'Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)', 'orgStudyIdInfo': {'id': 'RECHMPL23_0168'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MAD group', 'description': "* An oral and dental check-up will be carried out on the day of inclusion, and a sleep diary will be provided.\n* Compliance will be assessed after 6 months' wear.\n* As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life."}, {'label': 'CPAP group', 'description': "* An oral and dental check-up will be carried out on the day of inclusion.\n* Compliance will be assessed after 6 months' wear.\n* As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life."}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'email': 'c-francois@chu-montpellier.fr', 'phone': '0467335046'}], 'facility': 'CHU de MONTPELLIER', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Cindy FRANCOIS', 'role': 'CONTACT', 'email': 'c-francois@chu-montpellier.fr', 'phone': '06 84 31 62 08'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}