Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea: A Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Rate of recruitment
研究概览
简要总结
The goal of this study is to determine whether a randomized controlled trial using oropharyngeal exercises to treat sleep apnea is feasible. Continuous positive airway pressure (CPAP) is the standard therapy for Obstructive sleep apnea (OSA), but it is poorly tolerated by many patients. Oropharyngeal exercises (OPEs) which are commonly used by speech-language pathologists to improve oro-motor strength, may serve as a promising alternative approach. The main questions this study aims to answer are:
- Is it feasible to use an oropharyngeal exercise protocol in patients with sleep apnea?
- Will oropharyngeal exercises improve sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life
Participants will be randomized into a supervised OPE intervention arm vs. unsupervised OPE intervention arm vs. sham treatment for a 10-week/5-day per week/two 20-minute session exercise protocol. The exercises will be administered via an app and the investigators will assess feasibility, as well as several sleep-related and oro-motor physiological outcomes before treatment, immediately post-treatment, and 4 weeks post-treatment. The investigators will use the results of this feasibility trial to inform the sample size needed for a larger clinical trial that will determine the efficacy of using oropharyngeal exercises to treat OSA.
详细描述
- BACKGROUND
Obstructive sleep apnea (OSA) is a common disorder, and it is estimated that approximately one third of adult Canadians are at risk for obstructive sleep apnea (OSA), and approximately 20% of the general population has been diagnosed with OSA. Few effective treatment options are available to individuals with OSA. Continuous positive airway pressure (CPAP) is first-line therapy for treating moderate to severe OSA, and acts as a pneumatic splint to keep the airway open during sleep. Although CPAP is generally effective at treating OSA, it remains poorly tolerated by many patients; rates of non-adherence are estimated to be as high as 46 to 83%, with only one third of patients using CPAP at 4 years.
Oropharyngeal exercises (OPEs) are commonly used by speech-language pathologists to improve oro-motor strength and range of motion and serve as a promising alternative approach to treat OSA. Studies conducted so far have demonstrated that oropharyngeal exercises may be beneficial in the treatment of OSA. However, two recent systematic reviews concluded that the quality of the available evidence was low and larger blinded studies were needed. 2. RATIONALE
Due to poor rates of adherence, there is a major clinical need to develop alternative treatments to CPAP for OSA that are effective and well-tolerated. While oropharyngeal exercises appear to be a highly promising alternative approach to treat OSA, their efficacy in reducing OSA severity has not been established, and feasibility of this approach has not been demonstrated. 3. STUDY GOALS
Research Question: Is a randomized controlled trial (RCT) of an oropharyngeal exercise regimen in patients with OSA feasible?
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with OSA (defined as an apnea-hypopnea index ≥10/hr) in whom >50% of the respiratory events are obstructive in nature
- •Patients who are unwilling to use CPAP or have been unable to tolerate CPAP after at least a 2-week trial
- •Patients who are also not using an equipment-based treatment modality (e.g. PAP therapy, a dental appliance, or hypoglossal nerve stimulation) or surgery to manage their OSA.
排除标准
- •Planned airway surgery, use of CPAP, a dental appliance, or other equipment-based treatment modality to manage OSA during the course of the study
- •Central respiratory events account for ≥50% of the overall apnea-hypopnea index
- •Reduced cognition (MoCA<18)
- •Any significant neurological condition that could impact oropharyngeal activity
- •Use of medications that may impact tone of the upper airway (e.g. hypnotics, opiates) ≥3 nights per week during the 4 weeks prior to randomization
- •Use of a medical device that would interfere with the use of the home sleep apnea test
- •Plans to move to another city during the study that would impact compliance.
研究组 & 干预措施
Supervised Oropharyngeal Exercises
The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.
干预措施: Oropharyngeal Exercises (Behavioral)
Unsupervised Oropharyngeal Exercises
The participant will perform the oropharyngeal exercises that strengthen the tongue and pharyngeal muscles. The protocol will be delivered via a tablet-based app. After the initial training there will be no further scheduled interactions with the study staff except during the follow-up telephone calls and study visits.
干预措施: Oropharyngeal Exercises (Behavioral)
Supervised Sham Exercises
The participant will perform sham control exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength. The speech language pathologist will call or conduct videoconference visits with participants 1, 3, 5, 7 and 9 weeks after the baseline assessment to provide re-training (if needed) and to troubleshoot technical issues related to the use of the app.
干预措施: Sham Exercises (Behavioral)
结局指标
主要结局
Rate of recruitment
时间窗: 2 years
The study team will maintain logs to track the number of patients screened, found to be eligible, and randomized into the trial; we will also track dropouts
Patient adherence with the study exercises
时间窗: 10 weeks
Patient adherence with the study exercises will be tracked (in minutes) by the OPEX app that will deliver the oropharyngeal/sham exercises. We will compute the percentage of exercises completed.
Ability to ascertain Obstructive Sleep Apnea (OSA) severity
时间窗: 14 weeks
Ability to ascertain OSA severity, as assessed by completion rates for the three home sleep apnea tests at baseline, post-training and retention. A home sleep apnea test will be considered "completed" if ≥4 hours of flow, effort, and oxygen evaluation are obtained. The cut-off of ≥4 hours was selected as it has been recommended by clinical practice guidelines and previously used in prior home sleep apnea test feasibility studies.
次要结局
- Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index)(Baseline to 10 weeks (post-training) and 14 weeks (retention))
- Change in Lowest Oxygen Desaturation(Baseline to 10 weeks (post-training) and 14 weeks (retention))
- Change in Objective sleep quality(Baseline to 10 weeks (post-training) and 14 weeks (retention))
- Change in Objective sleep quantity(Baseline to 10 weeks (post-training) and 14 weeks (retention))
- Change in Sleep Quality (as assessed by the Pittsburgh Sleep Quality Index)(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Change in Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Change in Mood (as assessed by the Beck Depression Inventory)(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Change in Workplace performance (as assessed by the Work Limitations Questionnaire)(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Change in Self-reported Quality of Life as assessed by the EQ-5D-5L(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Change in Self-reported Quality of Life (as assessed by the SF-36 Questionnaire)(Baseline to 2 weeks, 6 weeks, 10 weeks (post-training), 12 weeks, 14 weeks (retention))
- Acceptability, Appropriateness, and Feasibility of Intervention Measure(10 weeks)
研究者
Mark Boulos, MD
Principal Investigator
Sunnybrook Health Sciences Centre