Development and Investigation of the ApneaTheraPlay

NCT07214636 | Not Yet Recruiting

• 1 other identifier: E-10840098-202.3.02-6266
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Apnea, Obstructive; Exercise Addiction; Physiotherapy and Rehabilitation

Keywords

Apnea; Exercise; Exergame; Physiotherapy and Rehabilitation; CPAP

Outcome Measures

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.

  0.,12., and 24. weeks

Secondary Outcomes (22)

• Oxygen saturation (SaO₂)

  0.,12., and 24. weeks

• Pittsburgh Sleep Quality Index (PSQI)

  0.,12., and 24. weeks

• The Insomnia Severity Index (ISI)

  0.,12., and 24. weeks

• Epworth Sleepiness Scale (ESS)

  0.,12., and 24. weeks

• Functional Sleep Outcomes Questionnaire (FOSQ-10)

  0.,12., and 24. weeks

Study Arms (3)

Structured Pre-Sleep Exercise Group (SPEG)

EXPERIMENTAL

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.

Behavioral: Structured Pre-Sleep Exercise

ApneaTheraPlay (ATP) Group

EXPERIMENTAL

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.

Behavioral: ApneaTheraPlay (ATP)

Control Group (CG)

NO INTERVENTION

Participants in this group will use a physician-prescribed Continuous Positive Airway Pressure (CPAP) device and sleep with CPAP every night for 12 weeks. After the study is completed, participants in this group will also be turned on to the ApneaTheraPlay system and will be encouraged to practice the exercises.

Interventions

ApneaTheraPlay (ATP) BEHAVIORAL

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.

ApneaTheraPlay (ATP) Group

Structured Pre-Sleep Exercise BEHAVIORAL

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.

Structured Pre-Sleep Exercise Group (SPEG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol Universty

Istanbul, Göztepe Neighborhood, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gülay Aras Bayram

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülay Aras Bayram, PhD

CONTACT

05054966284; garas@medipol.edu.tr

Gülay Aras Bayram

CONTACT

05054966284; garas@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers performing the assessments and the statistician performing the statistical analysis will be blinded to the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The randomized controlled, single-blind study

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 9, 2025
• Study Start: May 2, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)