Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-31 @ 9:40 AM
Study NCT ID:
NCT04731168
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Sleep Apnea After General Anaesthesia With a MAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}]}, '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supine AHI', 'timeFrame': 'Postoperative night 1', 'description': 'Apnea-Hypopnea index in the supine position'}], 'secondaryOutcomes': [{'measure': 'Global AHI', 'timeFrame': 'Postoperative night 1', 'description': 'Gobal Apnea-Hypopnea index: the number of apnoea and hypopnoea per hour of recording'}, {'measure': 'OAI', 'timeFrame': 'Postoperative night 1', 'description': 'Obstructive apnoea index: the number of apnoea from an obstructive origin per hour of recording'}, {'measure': 'CAI', 'timeFrame': 'Postoperative night 1', 'description': 'Central apnoea index: the number of apnoea from a central origin per hour of recording'}, {'measure': 'Hypopnea index', 'timeFrame': 'Postoperative night 1', 'description': 'Hypopnea index: the number of hypopnoea per hour of recording'}, {'measure': 'ODI', 'timeFrame': 'Postoperative night 1', 'description': 'Obstruction desaturation index: number of oxygen desaturation (≥3%) episodes per hour of sleep.'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Postoperative night 1', 'description': 'Respiratory Rate'}, {'measure': 'Percentage of supine time', 'timeFrame': 'Postoperative night 1', 'description': 'Percentage of supine time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-operative Medicine', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': "Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- adult patient undergoing any lower limb surgery\n\nExclusion Criteria:\n\n* continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea,\n* presence of severe respiratory or cardiovascular disease\n* preoperative consumption of benzodiazepine,\n* chronic use of opioids \\> 30 mg/day morphine equivalent\n* no tooth\n* patient known for malignant hyperthermia'}, 'identificationModule': {'nctId': 'NCT04731168', 'acronym': 'PoMAD', 'briefTitle': 'Prevention of Sleep Apnea After General Anaesthesia With a MAD', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020-01177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'MAD', 'description': 'Patients will have a mandibular advancement device during the first postoperative night', 'interventionNames': ['Device: Mandibular advancement device']}], 'interventions': [{'name': 'Mandibular advancement device', 'type': 'DEVICE', 'description': 'Patients will have a mandibular advancement device during the first postoperative night', 'armGroupLabels': ['MAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois and University of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program director of regional anaesthesia', 'investigatorFullName': 'Eric Albrecht', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}