Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-29 @ 6:42 PM
Study NCT ID:
NCT06471751
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': 'At 3 months', 'description': 'AHI is measured by polygraphy or polysomnography. It is not a score'}], 'secondaryOutcomes': [{'measure': 'Maximum inspiratory pressure measurement (cmH2O)', 'timeFrame': 'At 3 and 9 Months', 'description': 'Measured by POWERbreathe® K5'}, {'measure': 'Neck circumference (cm)', 'timeFrame': 'At 3 months', 'description': 'The neck circumference is measured by Magnetic Resonance Imagery (RMI)'}, {'measure': 'Epworth sleepiness score', 'timeFrame': 'At 3 and 9 Months', 'description': 'Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness'}, {'measure': 'Pittsburgh Sleep quality index', 'timeFrame': 'At 3 and 9 Months', 'description': 'Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality'}, {'measure': 'Quality of life scale : Short Form 12 (SF12)', 'timeFrame': 'At 3 and 9 Months', 'description': 'Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life'}, {'measure': 'PICOT fatigue scale', 'timeFrame': 'At 3 and 9 Months', 'description': 'Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness'}, {'measure': 'AHI (Apnea-Hypopnea Index)', 'timeFrame': 'At 9 months', 'description': 'AHI is measured by polygraphy or polysomnography It is not a score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inspiratory Muscles Training', 'Oropharyngeal training'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.', 'detailedDescription': 'For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate SAHOS (15 ≤ AHI ≤30);\n* Body Mass Index (BMI) \\< 35 ;\n* Patient affiliated or entitled to a social security scheme;\n* Patient having signed a consent to participate in the study.\n\nExclusion Criteria:\n\n* Excessive daytime sleepiness: Epworth sleepiness score \\> 10 ;\n* Professional driving and history of accidents related to sleepiness;\n* Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;\n* Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;\n* Patients who have stopped CPAP or orthosis treatment in less than one month;\n* Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;\n* Uncompensated heart failure, thoracic sternotomy surgery \\< 4 months;\n* Marked osteoporosis with history of rib fractures;\n* History of spontaneous pneumothorax;\n* Severe asthma;'}, 'identificationModule': {'nctId': 'NCT06471751', 'acronym': 'REMI SAHOS', 'briefTitle': 'Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome', 'orgStudyIdInfo': {'id': '23GI019'}, 'secondaryIdInfos': [{'id': '2024-A00601-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strengthening muscles group', 'description': 'Home training to strengthen Inspiratory and Oropharyngeal muscles', 'interventionNames': ['Other: Inspiratory and Oropharyngeal Muscle Strengthening']}, {'type': 'NO_INTERVENTION', 'label': 'No training group', 'description': 'No intervention'}], 'interventions': [{'name': 'Inspiratory and Oropharyngeal Muscle Strengthening', 'type': 'OTHER', 'description': 'Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises.\n\nThe sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device.', 'armGroupLabels': ['Strengthening muscles group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien BAILLIEUL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine ZELLAG, physiotherapist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pierre LABEIX, physiotherapist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Amandine ZELLAG, physiotherapist', 'role': 'CONTACT', 'email': 'amandine.zellag@chu-st-etienne.fr', 'phone': '(0)4 77 12 73 93', 'phoneExt': '+33'}, {'name': 'Pierre LABEIX, physiotherapist', 'role': 'CONTACT', 'email': 'pierre.labeix@chu-st-etienne.fr'}], 'overallOfficials': [{'name': 'Amandine Zellag', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association aide à la recherche médicale de proximité (AIRE)', 'class': 'UNKNOWN'}, {'name': "Conseil national de l'ordre des masseurs-kinésithérapeutes", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}