Development and Investigation of the ApneaTheraPlay (NCT07214636) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development and Investigation of the ApneaTheraPlay
Turkey (Türkiye)54 participantsStarted 2026-05-02
Plain-language summary
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 only keep a physical activity diary.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, neur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.