[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Centre Hospitalier Régional d'Orléans","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inspiratory muscle training group","EXPERIMENTAL","Step 1:\n\nDuring the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP):\n\n* Introduction of CPAP\n* Epworth Sleepiness Scale (ESS)\n* Maximum Inspiratory Pressure (MIP) measurement\n* Explanation of exercise program and use of POWERBreathe\n\nStep 2:\n\n6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS)\n\nStep 3:\n\nFollow-up visit at 12 weeks after introduction of CPAP:\n\n* Review of CPAP implementation\n* Epworth Sleepiness Scale (ESS)\n* MIP measurement",[13],"Other: Inspiratory muscle training",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Step 1:\n\nDuring the consultation to diagnose obstructive sleep disorder with the pulmonologist (following polysomnography) to set up continuous positive airway pressure (CPAP):\n\n* Introduction of CPAP\n* Epworth Sleepiness Scale (ESS)\n* Maximum Inspiratory Pressure (MIP) measurement\n\nStep 2:\n\n6-week telephone follow-up with measurement of Epworth Sleepiness Scale (ESS)\n\nStep 3:\n\nFollow-up visit at 12 weeks after introduction of CPAP:\n\n* Review of CPAP implementation\n* Epworth Sleepiness Scale (ESS)\n* MIP measurement",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Inspiratory muscle training","Description of a typical session:\n\nSession duration: between 12 and 20 minutes 3 cycles of 30 repetitions with 1 minute of break between each cycle. The patient should inhale as hard as possible against an inspiratory resistance generated by a valve device.",[9],[25],{"name":26,"affiliation":27,"role":28},"Marie DEVAUX, Dr","CHU d'Orléans","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Aurelie DESPUJOLS, Msc","CONTACT","+332 38 74 40 71","aurelie.despujols@chu-orleans.fr",[36],{"facility":37,"status":38,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Chu Orleans","RECRUITING","Orléans","France","FR",{"type":43,"coordinates":44},"Point",[45,46],1.90407,47.90248,{"lat":46,"lon":45},[49,52],{"name":50,"role":32,"phone":18,"phoneExt":18,"email":51},"Marie DEVAUX","marie.devaux@chu-orleans.fr",{"name":50,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100525118","effect-of-inspiratory-muscle-training-in-obstructive-sleep-apnea-syndrome-100525118",false,"NCT06117579","Effect of Inspiratory Muscle Training in Obstructive Sleep Apnea Syndrome.","Effect of Inspiratory Muscle Training on Daytime Sleepiness in Obstructive Sleep Apnea Syndrome : Prospective Randomized Controlled Trial","NOCTURNE","Inclusion Criteria:\n\n* patients over 18 years of age with\n* OSA with an Apnea Hypopnea Index ≥ 5 requiring CPAP\n\nExclusion Criteria:\n\n* Sleep apnea of neurological or mixed origin,\n* Contraindication to or refusal of CPAP,\n* Cognitive disorders,\n* protected persons (under guardianship or curatorship),\n* persons under court protection,\n* persons not affiliated to a social security scheme\n* pregnant or breast-feeding women.","ALL","18 Years",{"count":66,"type":67},58,"ESTIMATED","INTERVENTIONAL",[70],"NA","Sleep apnea-hypopnea syndrome is a sleep-related respiratory disorder characterized by partial or total interruptions in breathing during sleep. The majority of syndromes involve an obstructive mechanism (OSA), caused by a reduction in the caliber of the upper airway (UA), most often associated with hypotonia of the surrounding muscles, preventing air from entering the UA during inspiration. The clinical consequences of this syndrome are excessive fatigue and daytime sleepiness, which have a negative impact on the quality of life of patients.\n\nDespite the positive results on apnea-hypopnea index and daytime sleepiness of continuous positive airway pressure (today's reference treatment), its 3-year compliance rate (i.e 59.9% according to a study by Abdelghani et al points to the need to develop other associated therapies.\n\nSeveral studies have demonstrated the efficacy of physiotherapy, such as physical activity and oro-pharyngeal muscle strengthening, notably on the apnea-hypopnea index and daytime sleepiness measured by the Epworth scale.\n\nFew studies have investigated the effect of inspiratory muscle training (IMT), even though the use of the inspiratory musculature (i.e. the diaphragm) is a means of supplementing the peri-pharyngeal muscles, as it helps to maintain the permeability of the upper airways. Inspiratory muscle training (IMT) could therefore be considered as part of the physiotherapeutic management of the OSA. The heterogeneity of current results concerning IMT in OSA , but above all the lack of evidence that it is dangerous, means that new clinical studies could be carried out in an attempt to demonstrate its efficacy. Our research hypothesis is therefore as follows: Implementing an inspiratory muscle strengthening protocol in patients suffering from OSA can reduce daytime sleepiness.",[73],"Obstructive Sleep Apnea of Adult",[75,21],"Obstructive Sleep Apnea","2025-12-22",{"date":78,"type":79},"2025-12-30","ACTUAL",{"date":81,"type":79},"2024-06-26",{"date":83,"type":67},"2027-01-25",{"name":5,"class":6},1]