Development and Investigation of the ApneaTheraPlay
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Structured Pre-Sleep Exercise
BehavioralParticipants 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)
BehavioralParticipants 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.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Structured Pre-Sleep Exercise Group (SPEG)Experimental treatment 1 intervention
Group B: ApneaTheraPlay (ATP) GroupExperimental treatment 1 intervention
Group C: Control Group (CG)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Apnea-hypopnea index (AHI)
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.
Time frame
0.,12., and 24. weeksSecondary outcomes
1
Oxygen saturation (SaO₂)
This is the percentage of hemoglobin in the blood that is saturated with oxygen. It is a key indicator of respiratory function. As part of the project, participants will be provided with a Huawei GT3 Pro smartwatch (Huawei Technologies Co., Ltd., Shenzhen, China). The smartwatch will monitor and record individuals' SaO₂ levels day and night. A normal oxygen saturation level generally ranges from 95% to 100%, while values below 90% indicate hypoxia. Data from the watch will be used for comparison and follow-up with data from polysomnography.
Time frame
0.,12., and 24. weeks2
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a widely recognized 19-item self-report questionnaire used to assess subjective sleep quality and disturbances over a month. Subjective sleep quality assesses multiple dimensions of sleep, including sleep latency, duration, efficiency, disturbances, use of sleeping pills, and daytime dysfunction. Each component is scored on a scale of 0 to 3, and the total score ranges from 0 to 21; higher scores indicate poorer sleep quality. Scores above 5 are indicative of poor sleep quality.
Time frame
0.,12., and 24. weeks3
The Insomnia Severity Index (ISI)
This is a widely used self-report questionnaire designed to assess the severity of insomnia symptoms and their impact on daily functioning. It consists of seven items, each rated on a five-point Likert scale (0-4), and assesses difficulties falling asleep, staying asleep, early morning awakening, sleep dissatisfaction, interference with daytime activities, perception of sleep problems by others, and distress caused by sleep difficulties. The total ISI score ranges from 0 to 28, with higher scores indicating more severe insomnia symptoms. Scores are categorized as follows: no clinically significant insomnia (score of 0-7); subthreshold insomnia (score of 8-14); moderate insomnia (score of 15-21); and severe insomnia (score of 22-28).
Time frame
0.,12., and 24. weeks4
Epworth Sleepiness Scale (ESS)
This is a self-report questionnaire designed to assess daytime sleepiness. The ESS consists of eight items, each rated on a 4-point scale (0-3), and measures the likelihood of falling asleep during activities such as reading, watching television, sitting in a public place, or traveling as a passenger. The total score ranges from 0 to 24, with higher scores indicating greater levels of daytime sleepiness. A score of 0-10 is considered normal, while scores above 10 indicate varying degrees of excessive daytime sleepiness.
Time frame
0.,12., and 24. weeksSponsors and contacts
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Source ClinicalTrials.gov