Development and Investigation of the ApneaTheraPlay

Официальное название

Development and Investigation of the Effectiveness of a Digital Video-Based Game Exercise System (ApneaTheraPlay) for Individuals With Obstructive Sleep Apnea Syndrome

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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/tr
• Поведенческое 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 exercis

Первичные конечные точки

• Apnea-hypopnea index (AHI) [Срок оценки: 0.,12., and 24. weeks]

Вторичные конечные точки (12)

• Oxygen saturation (SaO₂) [Срок оценки: 0.,12., and 24. weeks]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: 0.,12., and 24. weeks]
• The Insomnia Severity Index (ISI) [Срок оценки: 0.,12., and 24. weeks]
• Epworth Sleepiness Scale (ESS) [Срок оценки: 0.,12., and 24. weeks]
• Functional Sleep Outcomes Questionnaire (FOSQ-10) [Срок оценки: 0.,12., and 24. weeks]
• Subjective sleepiness and sleep quality [Срок оценки: 0.,12., and 24. weeks]
• The Chalder Fatigue Scale (CFS) [Срок оценки: 0.,12., and 24. weeks]
• MIP-MEP measurement [Срок оценки: 0.,12., and 24. weeks]
• Forced Vital Capacity (FVC) measurement [Срок оценки: 0.,12., and 24. weeks]
• FEV₁ (Forced Expiratory Volume in 1 Second) [Срок оценки: 0.,12., and 24. weeks]
• FEV1/FVC ratio [Срок оценки: 0.,12., and 24. weeks]
• FEF 25%-75% (Maximal Mid-Expiratory Flow Rate) [Срок оценки: 0.,12., and 24. weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol Universty — Istanbul

Публикации

• Aras Bayram G, Tarakci D, Ergezen Sahin G, Savas Cevlan G, Ceylan A, Atilgan E, Ozkan K, Kunter E. Development and investigation of the efficacy of an interactive, web-based game exercise system (ApnoeaTheraPlay) for individuals with obstructive sleep apnoea syndrome: study protocol for a randomised, single-blind, controlled trial. BMJ Open. 2026 Apr 8;16(4):e117541. doi: 10.1136/bmjopen-2026-1175 PMID 41951254

Идентификаторы

NCT: NCT07214636 · E-10840098-202.3.02-6266

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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