[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552335":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":56,"overallOfficials":61,"centralContacts":65,"locations":75,"responsibleParty":106,"collaborators":108,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":37,"enrollmentInfo":123,"targetDuration":37,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":94,"whyStopped":37,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Apnea-Hypopnea Index (AHI)","AHI is measured by polygraphy or polysomnography. It is not a score","At 3 months",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Maximum inspiratory pressure measurement (cmH2O)","Measured by POWERbreathe® K5","At 3 and 9 Months",{"measure":19,"description":20,"timeFrame":12},"Neck circumference (cm)","The neck circumference is measured by Magnetic Resonance Imagery (RMI)",{"measure":22,"description":23,"timeFrame":17},"Epworth sleepiness score","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":25,"description":26,"timeFrame":17},"Pittsburgh Sleep quality index","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":28,"description":29,"timeFrame":17},"Quality of life scale : Short Form 12 (SF12)","Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life",{"measure":31,"description":32,"timeFrame":17},"PICOT fatigue scale","Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness",{"measure":34,"description":35,"timeFrame":36},"AHI (Apnea-Hypopnea Index)","AHI is measured by polygraphy or polysomnography It is not a score","At 9 months",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","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.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Strengthening muscles group","EXPERIMENTAL","Home training to strengthen Inspiratory and Oropharyngeal muscles",[51],"Other: Inspiratory and Oropharyngeal Muscle Strengthening",{"label":53,"type":54,"description":55,"interventionNames":37},"No training group","NO_INTERVENTION","No intervention",[57],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":37},"Inspiratory and Oropharyngeal Muscle Strengthening","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.",[47],[62],{"name":63,"affiliation":5,"role":64},"Amandine Zellag","PRINCIPAL_INVESTIGATOR",[66,72],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Amandine ZELLAG, physiotherapist","CONTACT","(0)4 77 12 73 93","+33","amandine.zellag@chu-st-etienne.fr",{"name":73,"role":68,"phone":37,"phoneExt":37,"email":74},"Pierre LABEIX, physiotherapist","pierre.labeix@chu-st-etienne.fr",[76,92],{"facility":77,"status":78,"city":79,"state":37,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"CHU de Grenoble","NOT_YET_RECRUITING","Grenoble","38000","France","FR",{"type":84,"coordinates":85},"Point",[86,87],5.71479,45.17869,{"lat":87,"lon":86},[90],{"name":91,"role":64,"phone":37,"phoneExt":37,"email":37},"Sébastien BAILLIEUL, MD",{"facility":93,"status":94,"city":95,"state":37,"zip":96,"country":81,"countryCode":82,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Centre Hospitalier Universitaire","RECRUITING","Saint-Etienne","42055",{"type":84,"coordinates":98},[99,100],4.39,45.43389,{"lat":100,"lon":99},[103,104],{"name":67,"role":64,"phone":37,"phoneExt":37,"email":37},{"name":73,"role":105,"phone":37,"phoneExt":37,"email":37},"SUB_INVESTIGATOR",{"type":107,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[109,112],{"name":110,"class":111},"Association aide à la recherche médicale de proximité (AIRE)","UNKNOWN",{"name":113,"class":111},"Conseil national de l'ordre des masseurs-kinésithérapeutes","100552335","strengthening-inspiratory-and-oropharyngeal-muscles-in-moderate-obstructive-sleep-apnea-hypopnea-syndrome-100552335",false,"NCT06471751","Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome","REMI SAHOS","Inclusion Criteria:\n\n* Moderate SAHOS (15 ≤ AHI ≤30);\n* Body Mass Index (BMI) \\\u003C 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 \\\u003C 4 months;\n* Marked osteoporosis with history of rib fractures;\n* History of spontaneous pneumothorax;\n* Severe asthma;\n* Perforated eardrum or any other ear condition;\n* Pulmonary hypertension;\n* History of pharyngeal surgery to treat sleep apnea;\n* Pregnant women or women in labor;\n* Individuals deprived of their liberty or hospitalized without consent;\n* Adults subject to legal protective measures (guardianship or conservatorship).\n\nContraindications for MRI\n\n* Patient with claustrophobia;\n* Patient for whom MRI is contraindicated (pacemaker, metallic heart valve, metallic foreign body in the eye).","ALL","18 Years",{"count":124,"type":125},38,"ESTIMATED","INTERVENTIONAL",[128],"NA","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.",[131],"Obstructive Sleep Apnea",[133,134],"Inspiratory Muscles Training","Oropharyngeal training","2026-09-23",{"date":137,"type":138},"2026-09-25","ACTUAL",{"date":140,"type":138},"2024-12-30",{"date":142,"type":125},"2027-08-01",{"name":5,"class":6},2]