Status:
NOT_YET_RECRUITING
Development and Investigation of the ApneaTheraPlay
Lead Sponsor:
Medipol University
Conditions:
Apnea, Obstructive
Exercise Addiction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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, an...
Detailed Description
Obstructive sleep apnea syndrome (OUAS) is a common sleep disorder caused by recurrent collapse of the upper airways during sleep. Continuous positive airway pressure (CPAP) devices are one of the mos...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07214636
Start Date
December 1 2025
End Date
December 1 2027
Last Update
October 9 2025
Active Locations (1)
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1
Istanbul Medipol Universty
Istanbul, Göztepe Neighborhood, Turkey (Türkiye), 34810