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Development and Investigation of the ApneaTheraPlay

RecruitingNAAges 18 Years - 65 YearsAllMedipol University
NCT07214636 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This 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 onl

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18-65 years of age * Individuals diagnosed with mild, moderate, or severe OSAS (AHI 5-30 events/hour) based on laboratory diagnostic polysomnography assessments * 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 * Those with habitual snoring * 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 * Participants must have sufficient physical function to follow the exercise instructions * Familiarity with mobile health applications, as assessed by the VAS, and a willingness to participate in these exercises of \>7 * Not having participated in physiotherapy-based interventions targeting OSAS in the last 3 months * A score of 68 or higher on the System Usability Scale (SUS) Exclusion Criteria: * • BMI \> 40 kg/m2 * Serious drug or alcohol abuse * Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns or exercise performance * Pregnancy or postpartum (\<6 months) due to hormonal effects on sleep and respiratory function * 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) * History of stroke * Presence of any significant respiratory, neuromuscular, or other disorder causing hypercapnia * Systemic disease associated with an inflammatory entity (e.g., arthritis, sarcoidosis, vasculitis, lupus) * Craniofacial deformity * Presence of secondary respiratory diseases such as severe upper airway obstruction or COPD * Presence of dysphagia * Presence of a frenulum restricting tongue movement
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What it tests

  • Structured Pre-Sleep Exercise
  • ApneaTheraPlay (ATP)
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Where

1 site
Istanbul Medipol Universty
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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