Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.
详细描述
Background
A nonintrusive, inexpensive behavioral approach is emerging as a promising alternative to the management of obstructive sleep apnea (OSA). Generally referred to as myofunctional therapy (MFT), the approach involves exercising the muscles of the oropharynx and respiratory system.The exercises are intended to improve muscle strength and tone so that the muscular structures of the upper airway improve their neuromuscular responsiveness to breathing and resist collapsing into the airway during sleep. They are relatively simple to implement and train, but the regimen requires high-dosage practice and strict dedication to habituate. There is a need for an MFT protocol to be delivered in a consistent manner that is simple, sustainable, and motivating. This study takes advantage of recent low-tech tools that appear to elicit the desired muscle actions achieved with MFT.
Participant Recruitment
Participants are recruited from the Sleep Clinic at Walter Reed National Military Medical Center if they receive a new diagnosis of obstructive sleep apnea (AHI >5) based on standard-of-care polysomnography (PSG) or if they do not successfully use a standard first-line treatment. After providing informed consent and passing screening tests, they are randomized into one of two behavioral interventions.
Interviews will determine whether participants have a history of TBI. Participants in the two intervention arms will be block stratified based on +/- TBI and TBI severity. The groups will also be stratified based on OSA severity.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •New diagnosis of OSA (AHI, ≥ 5) or failure of first-line OSA treatment;
- •Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months;
- •Ability to follow directions and perform the required exercises;
- •Age between 18-65 yr.
排除标准
- •Current use of OSA treatment;
- •Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia);
- •Severe nasal obstruction; 4) severe ankyloglossia; 4) craniofacial abnormality; 5) severe pulmonary disease; 6) severe post-traumatic stress disorder; 7) very severe insomnia; 8) body mass index (BMI) ≥30 kg/m2
研究组 & 干预措施
Myofunctional Therapy
干预措施: High-Resistance Breathing and Drinking Exercises (Behavioral)
Relaxation Therapy
干预措施: Low-Resistance Breathing and Drinking Exercises (Behavioral)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: From enrollment to end of three-month intervention
AHI is the number of apneic and hypopneic episodes per hour of sleep. The scores start at zero, meaning no events are taking place. A mild score falls in the range of 5-15; moderate 15-30, and a severe diagnosis is 30 or more events per hour. Pre-intervention AHI is obtained from standard-of-care in-clinic sleep study. Post-intervention AHI is obtained from an in-clinic sleep study conducted as part of this research.
次要结局
- SpO2(From enrollment to end of three-month intervention)
- Snore Index(From enrollment to end of three-month intervention)
- Epworth Sleepiness Scale (ESS)(From enrollment to end of three-month intervention with option for additional three-week follow-up)
- Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10)(From enrollment to end of three-month intervention with option for additional three-week follow-up)