Development and Investigation of the ApneaTheraPlay

Condition(s) studied

Investigational drug(s) / intervention(s)

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/training 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/training 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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Apnea-hypopnea index (AHI) — 0.,12., and 24. weeks
  This will be measured objectively during a Level 1 sleep study (polysomnography). The AHI measures the number of apnea and hypopnea events per hour of sleep; 0 to 4 events indicates normal, 5 to 14 events indicates mild OSAS, 15 to 30 events indicates moderate OSAS, and greater than 30 events indicates severe OSAS. A change in AHI of at least 15 events will be considered clinically significant to determine the clinical effectiveness of the intervention.

Trial sites (1)

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