Development and Investigation of the ApneaTheraPlay

Medipol University

Status: Begins enrollment in 2 months

Conditions: Apnea, Obstructive; Exercise Addiction; Physiotherapy and Rehabilitation

Treatments: Behavioral: Structured Pre-Sleep Exercise; Behavioral: ApneaTheraPlay (ATP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07214636

E-10840098-202.3.02-6266

Details and patient eligibility

About

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.

Full 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 most widely used clinical modalities for treatment. However, the literature reports that compliance with CPAP is low, with non-compliance rates ranging from 46% to 83%. As an alternative and supportive method, exercise has been proven to have positive effects on strengthening respiratory muscles, improving upper airway function and improving sleep quality. Recent studies generally focus on single or dual combined exercise protocols, but there is no comprehensive study on the integrated application of four different exercise types. Furthermore, there is limited evidence in the literature on the efficacy of performing exercises directly before sleep.

This project aims to develop and evaluate the effectiveness of a digital video-based gaming exercise platform (ApneaTheraPlay) that combines respiratory, aerobic, strengthening, and oropharyngeal exercises for individuals with OUAS. The project is designed to increase individual participation in the exercises and maintain patient motivation by using a web-based system that can be applied in the home environment prior to sleep.

The outcome of this project will be the development of a digital, video-based, gamified exercise application for people with OUAS that will both increase exercise compliance and support the effectiveness of CPAP use. In addition, the developed system will enable remote patient monitoring and guidance by providing a virtual clinical environment. This innovative approach to the literature will make an important contribution to the scientific evaluation of the effect of pre-sleep exercise on OUAS symptoms.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Structured Pre-Sleep Exercise Group (SPEG)

Experimental group

Description:

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.

Treatment:

Behavioral: Structured Pre-Sleep Exercise

ApneaTheraPlay (ATP) Group

Experimental group

Description:

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.

Treatment:

Behavioral: ApneaTheraPlay (ATP)

Control Group (CG)

No Intervention group

Description:

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.