Development and Investigation of the Effectiveness of a Digital Video-Based Game Exercise System (ApneaTheraPlay) for Individuals With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researchers performing the assessments and the statistician performing the statistical analysis will be blinded to the group assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •• 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
研究组 & 干预措施
Structured Pre-Sleep Exercise Group (SPEG)
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.
干预措施: Structured Pre-Sleep Exercise (Behavioral)
ApneaTheraPlay (ATP) Group
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.
干预措施: ApneaTheraPlay (ATP) (Behavioral)
Control Group (CG)
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.
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: 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.
次要结局
- Oxygen saturation (SaO₂)(0.,12., and 24. weeks)
- Epworth Sleepiness Scale (ESS)(0.,12., and 24. weeks)
- Day and night SaO₂ levels(0-24. weeks)
- System Usability Scale (SUS)(0.week)
- Pittsburgh Sleep Quality Index (PSQI)(0.,12., and 24. weeks)
- The Insomnia Severity Index (ISI)(0.,12., and 24. weeks)
- Functional Sleep Outcomes Questionnaire (FOSQ-10)(0.,12., and 24. weeks)
- Subjective sleepiness and sleep quality(0.,12., and 24. weeks)
- MIP-MEP measurement(0.,12., and 24. weeks)
- The Chalder Fatigue Scale (CFS)(0.,12., and 24. weeks)
- Forced Vital Capacity (FVC) measurement(0.,12., and 24. weeks)
- FEV₁ (Forced Expiratory Volume in 1 Second)(0.,12., and 24. weeks)
- FEV1/FVC ratio(0.,12., and 24. weeks)
- FEF 25%-75% (Maximal Mid-Expiratory Flow Rate)(0.,12., and 24. weeks)
- CPAP adherence data(0-24. weeks)
- Exercise Compliance(0-24. weeks)
- Daily step count(0-24. weeks)
- Heart rate variability (HRV)(0-24. weeks)
- Short Form-12 (SF-12)(0.,12., and 24. weeks)
- Quadriceps isometric muscle strength(0.,12., and 24. weeks)
- Hand Grip Strength(0.,12., and 24. weeks)
- The Hospital Anxiety and Depression Scale (HADS)(0.,12., and 24. weeks)
研究者
Gülay Aras Bayram
PhD
Medipol University