Development and Investigation of the ApneaTheraPlay

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedipol University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

• 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

Trial design

Treatments tested in this trial

  • Structured Pre-Sleep Exercise
  • ApneaTheraPlay (ATP)

Treatment groups

54 Participants
are divided into 3 treatment groups

Sponsors and collaborators