Myofunctional Therapy for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MFT treatment fidelity
研究概览
简要总结
The purpose of this study is to explore a new way to examine the function of the muscles using a technique called high-resolution manometry. The study will enroll 30 adults with OSA, all of whom will use the myofunctional therapy (MFT) devices for 3 months. High-resolution manometry will be used to measure the amount of pressure generated by the muscles of the throat when drinking water or breathing air, both with and without the MFT devices, and before and after the MFT intervention. If successful, this method can help us understand why sleep improves after MFT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adults aged 18-65
- •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
排除标准
- •Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia)
- •Severe nasal obstruction
- •Severe ankyloglossia
- •Craniofacial abnormality
- •Severe pulmonary disease
- •Severe post-traumatic stress disorder (PCL-5 > 33)
- •Very severe insomnia (ISI > 22)
- •Body mass index (BMI) ≥30 kg/m
- •History of TBI
- •Known oropharyngeal or esophageal dysphagia
- •Pregnancy
- •Allergy to topical anesthetic
- •Inability to fast for 6 hours
- •Recent facial trauma
- •Recent nasal, pharyngeal, laryngeal, or esophageal surgery
- •Known nasal, pharyngeal or esophageal obstruction
- •Current upper respiratory infection
- •Insufficient internet/computer access to participate in remote study visit
- •Severe excessive daytime sleepiness (risk of motor vehicle accidents)
- •Heart failure, recent stroke, heart attack, etc.
- •Nasal Obstruction Symptom Evaluation (NOSE) Scale >15
研究组 & 干预措施
Myofunctional Therapy
The intervention consists of 90 days of MFT (5-6 days/week) along with completing daily logs.
MFT will include high-intensity swallowing exercises and respiratory muscle strength training.
Before and after the MFT intervention period, there will be a research visit that includes answering questionnaires about symptoms and health, performing throat HRM, and assessing oral and facial muscles involved in swallowing.
干预措施: Myofunctional Therapy (Procedure)
结局指标
主要结局
MFT treatment fidelity
时间窗: Day 90
Treatment fidelity of two common MFTs (high-intensity swallowing exercises, respiratory muscle strength training) in individuals with OSA. Treatment fidelity will be determined via measuring the percent of sessions completed relative to the targeted number of sessions.
Pressure generation in posterior upper airway musculature
时间窗: Day 90
Comparison of pressure generation in posterior upper airway musculature before and after MFT intervention as assessed with HRM
次要结局
未报告次要终点