[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634452":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":51,"centralContacts":56,"locations":37,"responsibleParty":62,"collaborators":37,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":37,"enrollmentInfo":74,"targetDuration":37,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":37,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":37},{"fullName":5,"class":6},"Saint-Joseph University","OTHER",[8,15,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham + Standard of Care.","SHAM_COMPARATOR","Participants receive placebo breathing sessions with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations during the 12-week supervised intervention period.",[13,14],"Behavioral: Sham Breathing Sessions","Behavioral: Standard of Care Sleep-Hygiene and Lifestyle Counseling",{"label":16,"type":17,"description":18,"interventionNames":19},"Orofacial Myofunctional Therapy + Standard of Care","EXPERIMENTAL","Participants receive a structured orofacial myofunctional therapy program for 12 weeks, consisting of 3 sessions per day, each lasting approximately 8 minutes, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.",[20,14],"Behavioral: Orofacial Myofunctional Therapy",{"label":22,"type":23,"description":24,"interventionNames":25},"CPAP + Standard of Care","ACTIVE_COMPARATOR","Participants receive continuous positive airway pressure treatment for 12 weeks, with adherence targets of more than 4 hours per night, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.",[26,14],"Device: Continuous Positive Airway Pressure",{"label":28,"type":17,"description":29,"interventionNames":30},"Orofacial Myofunctional Therapy + CPAP + Standard of Care","Participants receive the full orofacial myofunctional therapy program and continuous positive airway pressure concurrently during the 12-week supervised intervention period, plus standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations.",[20,26,14],[32,38,42,47],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Sham Breathing Sessions","Placebo breathing sessions delivered with the same frequency of visits and reminders as the active orofacial myofunctional therapy arm.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Orofacial Myofunctional Therapy","Structured orofacial myofunctional therapy program delivered over 12 weeks, consisting of 3 sessions per day of approximately 8 minutes each. Participants assigned to OMT will receive a 30-minute training session delivered by a speech therapist, either face-to-face or via videoconference. Training includes exercise demonstration, guided practice, posture correction, and access to PDF handouts and instructional videos. Adherence will be monitored primarily using the Loop Habit Tracker application configured for 3 daily reminders; a paper logbook will be used when digital tracking is not feasible. Reinforcement messages will be sent every 48 hours, and a Day-30 videoconference will be conducted to review technique and troubleshoot barriers.",[28,16],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":37},"DEVICE","Continuous Positive Airway Pressure","Participants assigned to CPAP will receive a Week-1 telephone call to confirm installation and resolve technical issues, and a Week-6 adherence support visit to optimize mask fit and encourage use. Device-derived adherence metrics will include mean nightly use, P90\u002FP95 pressure, median pressure, and mask leak statistics.",[22,28],{"type":33,"name":48,"description":49,"armGroupLabels":50,"otherNames":37},"Standard of Care Sleep-Hygiene and Lifestyle Counseling","Standardized sleep-hygiene counseling and general non-pharmacological lifestyle recommendations provided uniformly to all participants, including regular sleep-wake schedules, avoidance of alcohol and sedatives before bedtime, reduction of evening screen exposure, optimization of the sleep environment, and encouragement of healthy dietary habits and physical activity aimed at gradual weight control.",[22,28,16,9],[52],{"name":53,"affiliation":54,"role":55},"Moussa Albert Riachy, MD","Hotel Dieu de France, Saint Joseph University, Beirut, Lebanon","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":37,"email":61},"Moussa Riachy, MD","CONTACT","+9613361672","moussa.riachy@hdf.usj.edu.lb",{"type":63,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100634452","orofacial-myofunctional-therapy-and-positive-airway-pressure-cpap-trial-for-mild-to-moderate-obstructive-sleep-apnea-100634452",false,"NCT07539870","Orofacial Myofunctional Therapy and Positive Airway Pressure-CPAP Trial for Mild-to-Moderate Obstructive Sleep Apnea","Isolated and Combined Effects of Orofacial Myofunctional Therapy and Continuous Positive Airway Pressure on the Apnea-Hypopnea Index and Mandibular Excursion in Adults With Mild-to-Moderate Obstructive Sleep Apnea: The OMPACT-OSA Randomized Controlled Trial","OMPACT-OSA","Inclusion Criteria:\n\n* Age 18 years or older.\n* Mild-to-moderate OSA (AHI 5.0-29.9 events\u002Fhour) confirmed by Type I polysomnography.\n* Protrusive excursion of at least 5 mm measured with the George Gauge.\n* No previous treatment with CPAP or OMT.\n* Ability to perform oropharyngeal exercises.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Severe obstructive sleep apnea (AHI 30 events\u002Fhour or higher) or urgent need for CPAP\n* Suspected or confirmed obesity hypoventilation syndrome, chronic ventilatory failure, or severe obesity associated with daytime hypercapnia or hypoxemia\n* Clinically significant insomnia, defined as an Insomnia Severity Index (ISI) score \\> 14 at screening.\n* Uncontrolled psychiatric or neurological conditions likely to substantially affect sleep quality or daytime symptoms independently of OSA (e.g., major depressive episode, severe anxiety disorder, chronic disabling migraine)., as judged by the investigator.\n* Current use of medications likely to affect sleep architecture, respiratory drive, or PAP tolerance, including chronic opioid therapy and other sedative medications judged incompatible with study participation.\n* Unstable or severe cardiovascular disease requiring priority standard management, including poorly controlled arrhythmia, nocturnal angina, decompensated heart failure, treatment-resistant hypertension, or recent acute coronary syndrome\n* Uncontrolled diabetes mellitus requiring treatment intensification, for example - HbA1c greater than 10% and\u002For symptomatic hyperglycemia\n* Neurological or ear-nose-throat disease affecting the upper airway\n* Craniofacial abnormalities\n* Maxillofacial surgery within the previous 6 months\n* Temporomandibular pain preventing completion of exercises\n* Active periodontitis\n* Pregnancy\n* Foreseeable non-adherence to the intervention\n* Inability to use CPAP despite standard fitting and troubleshooting, or any contraindication to CPAP treatment.\n* Ongoing CPAP or OMT at inclusion","ALL","18 Years",{"count":75,"type":76},168,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to evaluate the isolated and combined effects of orofacial myofunctional therapy (OMT) and continuous positive airway pressure (CPAP) in adults with mild-to-moderate obstructive sleep apnea. The main questions it aims to answer are whether OMT alone, CPAP alone, or combined OMT plus CPAP improves obstructive sleep apnea severity at Week 12, as measured by the apnea-hypopnea index (AHI), and whether these interventions improve mandibular excursion. Researchers will compare 4 groups-sham plus standard of care, OMT plus standard of care, CPAP plus standard of care, and combined OMT plus CPAP plus standard of care-to assess differences in respiratory and anatomical-functional outcomes. Participants will be randomized to 1 of the 4 study arms. During the 12-week supervised intervention phase, participants will receive their assigned intervention together with standardized sleep-hygiene and lifestyle counseling. Assessments include sleep recording, mandibular excursion measurements, questionnaires on sleepiness and sleep quality, dento-occlusal and anthropometric measurements, and treatment adherence monitoring. After Week 12, participants will enter an observational follow-up phase through Week 52 to evaluate durability of treatment effects, treatment persistence, symptom recurrence, and clinically indicated treatment modifications.",[82],"Obstructive Sleep Apnea",[84,39,44,85,86,87,88,89],"Mild-to-Moderate Obstructive Sleep Apnea","Apnea-Hypopnea Index","Mandibular Excursion","George Gauge","Jaw Motion Analyser","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-13",{"date":93,"type":94},"2026-04-20","ACTUAL",{"date":96,"type":76},"2026-05",{"date":98,"type":76},"2028-05",{"name":5,"class":6}]