[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609442":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":60,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":89,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Structured Pre-Sleep Exercise Group (SPEG)","EXPERIMENTAL","Individuals will complete a program consisting of 5-minute breathing, 10-minute aerobic, 5-minute strengthening, and 10-minute oropharyngeal exercises, three times a week for 12 weeks, for a total of 36 sessions.",[13],"Behavioral: Structured Pre-Sleep Exercise",{"label":15,"type":10,"description":16,"interventionNames":17},"ApneaTheraPlay (ATP) Group","Participants will exercise individually at pre-sleep times, three days a week, for 12 weeks, using a digital video-based game exercise system developed by researchers, for a total of 36 sessions.",[18],"Behavioral: ApneaTheraPlay (ATP)",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group (CG)","NO_INTERVENTION","Participants in this group will use a physician-prescribed Continuous Positive Airway Pressure (CPAP) device and sleep with CPAP every night for 12 weeks. After the study is completed, participants in this group will also be turned on to the ApneaTheraPlay system and will be encouraged to practice the exercises.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","Structured Pre-Sleep Exercise","Participants in this group will undergo a new program structured around exercises typically used individually or in combination in the literature, at pre-sleep times. Individuals will complete a program consisting of 5-minute breathing, 10-minute aerobic, 5-minute strengthening, and 10-minute oropharyngeal exercises, three times a week for 12 weeks, for a total of 36 sessions. Two-minute rest breaks will be provided between exercises. The exercises will be presented to users weekly as a video\u002Ftraining sheet prepared by the therapist. Individuals in this group will be monitored and tracked through the system to be developed. This group will only have access to this video\u002Ftraining sheet information in the user panel opened in the system. The system will remind users of the exercises as an exercise program, without gamification, and will provide instant data flow.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"ApneaTheraPlay (ATP)","Participants will exercise individually at pre-sleep times, three days a week, for 12 weeks, using a digital video-based game exercise system developed by researchers, for a total of 36 sessions. Access to the exercise program will be provided via a web system, and all time spent in the system and reactions will be recorded in a report. The ApneaTheraPlay system will implement programs consisting of breathing (5 minutes), aerobic (10 minutes), strengthening (5 minutes), and oropharyngeal exercises (10 minutes) in a predetermined progression.",[15],[35],{"name":36,"affiliation":5,"role":37},"Gülay Aras Bayram","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Gülay Aras Bayram, PhD","CONTACT","05054966284","garas@medipol.edu.tr",{"name":36,"role":41,"phone":42,"phoneExt":23,"email":43},[46],{"facility":47,"status":23,"city":48,"state":49,"zip":50,"country":51,"countryCode":23,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Istanbul Medipol Universty","Istanbul","Göztepe Neighborhood","34810","Turkey (Türkiye)",{"type":53,"coordinates":54},"Point",[55,56],28.94966,41.01384,{"lat":56,"lon":55},[59],{"name":36,"role":41,"phone":42,"phoneExt":23,"email":43},{"type":37,"investigatorFullName":36,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PhD","100609442","development-and-investigation-of-the-apneatheraplay-100609442",false,"NCT07214636","Development and Investigation of the ApneaTheraPlay","Development and Investigation of the Effectiveness of a Digital Video-Based Game Exercise System (ApneaTheraPlay) for Individuals With Obstructive Sleep Apnea Syndrome","Inclusion Criteria:\n\n* 18-65 years of age\n* Individuals diagnosed with mild, moderate, or severe OSAS (AHI 5-30 events\u002Fhour) based on laboratory diagnostic polysomnography assessments\n* Individuals diagnosed by a pulmonologist within the last year and who have started CPAP therapy for at most 12 months and who are regular users\n* Those with habitual snoring\n* All participants in the exercise group must have or have access to a phone, tablet, or computer compatible with SMART technologies using the exercise system app\n* Participants must have sufficient physical function to follow the exercise instructions\n* Familiarity with mobile health applications, as assessed by the VAS, and a willingness to participate in these exercises of \\>7\n* Not having participated in physiotherapy-based interventions targeting OSAS in the last 3 months\n* A score of 68 or higher on the System Usability Scale (SUS)\n\nExclusion Criteria:\n\n* • BMI \\> 40 kg\u002Fm2\n\n  * Serious drug or alcohol abuse\n  * Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns or exercise performance\n  * Pregnancy or postpartum (\\\u003C6 months) due to hormonal effects on sleep and respiratory function\n  * Any medical contraindication to physical activity (unstable coronary disease, decompensated heart failure) according to the American College of Sports Medicine (ACSM) exercise guidelines (American College of Sports Medicine, 2021)\n  * History of stroke\n  * Presence of any significant respiratory, neuromuscular, or other disorder causing hypercapnia\n  * Systemic disease associated with an inflammatory entity (e.g., arthritis, sarcoidosis, vasculitis, lupus)\n  * Craniofacial deformity\n  * Presence of secondary respiratory diseases such as severe upper airway obstruction or COPD\n  * Presence of dysphagia\n  * Presence of a frenulum restricting tongue movement",true,"ALL","18 Years","65 Years",{"count":74,"type":75},54,"ESTIMATED","INTERVENTIONAL",[78],"NA","Obstructive Sleep Apnea Syndrome (OSAS) is commonly treated with CPAP devices, but adherence rates are low. Exercise has been shown to strengthen respiratory muscles, improve upper airway function, and enhance sleep quality. However, most studies have examined only single or dual exercise protocols, and there is little evidence regarding integrated programs with four exercise types or their effects when performed directly before sleep.\n\nThis project aims to develop and evaluate ApneaTheraPlay (ATP), a digital gamified video-based exercise platform combining respiratory, aerobic, strengthening, and oropharyngeal exercises. The randomized controlled, double-blind study will allocate participants into three groups: ATP, a structured pre-sleep exercise group (SPEG), and a control group (CG). Intervention groups will exercise three times per week for 12 weeks, while the control group will only keep a physical activity diary.",[81,82,83],"Apnea, Obstructive","Exercise Addiction","Physiotherapy and Rehabilitation",[85,86,87,83,88],"Apnea","Exercise","Exergame","CPAP","NOT_YET_RECRUITING","2026-01-15",{"date":92,"type":93},"2026-01-20","ACTUAL",{"date":95,"type":75},"2026-05-02",{"date":97,"type":75},"2027-12-01",{"name":5,"class":6},1]