Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea

肌功能治疗对轻度至中度睡眠呼吸暂停患者预后的影响

• 批准号: 10311037
• 负责人: Carl J. Stepnowsky
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-10-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311037
• 关键词: Accidents; Age; Apnea; Breathing Exercises; Cardiovascular Diseases; Caring; Chronic; Continuous Positive Airway Pressure; Diabetes Mellitus; Diagnosis; Disease; Divorce; Drowsiness; Excessive Daytime Sleepiness; Exercise; Goals; Gold; Healthcare; Impairment; Intervention; Isometric Exercise; Isotonic Exercise; Lateral; Literature; Maintenance; Measures; Medical; Medical Device; Mental Depression; Methods; Motor Vehicles; Myofunctional Therapy; Neck; Obstructive Sleep Apnea; Oral; Oropharyngeal; Outcome; Outcome Measure; Participant; Patients; Performance at work; Phase; Provider; Publishing; Randomized; Recommendation; Rehabilitation therapy; Relaxation; Reporting; Resistant Hypertension; Risk; Severities; Severity of illness; Shoulder; Sleep; Sleep Apnea Syndromes; Soft Palate; Stretching; Symptoms; Therapeutic; Therapeutic Effect; Therapeutic Intervention; Time; Tongue; Veterans; Veterans Health Administration; Weight; Workplace; comorbidity; follow up assessment; functional status; high risk; improved; indexing; orofacial; primary outcome; programs; sleep quality; standard measure; treatment arm

Anticipated Impact on Veteran’s Healthcare: Sleep apnea is one of the most common chronic conditions in the Veterans Health Administration (VHA). Because of increased efforts at diagnosis, many VA sleep programs are now encountering higher levels of veterans diagnosed with mild-to- moderate obstructive sleep apnea (OSA). Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and can provide VHA patients and providers with a therapeutic option that does not require the use of an expensive and burdensome medical device at night while asleep. Project Background: The primary medical therapies for patients with OSA require the use of medical devices (continuous positive airway pressure (CPAP) or oral appliances), which are difficult for patients with mild-to-moderate disease to use regularly on a nightly basis. Because the majority of these patients often stop using these therapies, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA continues to worsen with increasing age and weight, which only compounds the risk of OSA consequences. OSA consequences include the increased risk of a range of medical comorbidities (e.g., diabetes, cardiovascular disease, treatment-resistant hypertension, and depression) and impairments in daytime functioning due to excessive daytime sleepiness, including increased for motor vehicle or workplace accidents, work performance impairments, and higher risk of divorce. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall). Project Objectives: The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT. Project Methods: We propose a 6-month randomized, controlled, non-blinded, single-center study of Orofacial Myofunctional Therapy (OMT) compared to sham Orofacial Myofunctional Therapy (sham OMT). Participants in the intervention arm will undergo 3-months of active OMT intervention while the sham OMT will be provided with recommendations of exercise and activities that do not have a therapeutic function or effect, including general breathing exercises, relaxation, and stretching of the neck and shoulders. The primary outcome measure for the study will be between-group change in the primary measure of OSA disease severity (apnea-hypopnea index). Important secondary aims will focus on patient functional status and OSA symptoms (e.g., excessive daytime sleepiness and sleep quality). [The primary study timepoint is 3 months, while the 6-month timepoint will assess the duration of therapeutic effect.]

对退伍军人的医疗保健的预期影响：睡眠呼吸暂停是最常见的慢性病之一 退伍军人卫生管理局（VHA）的条件。由于诊断的努力增加， 现在，许多VA睡眠计划正在遇到更高水平的退伍军人，被诊断为轻度至轻度 中度阻塞性睡眠呼吸暂停（OSA）。 Orofacity肌功能疗法（OMT）服用 OSA的康复方法，可以为VHA患者和提供者提供治疗选择 这不需要在晚上入睡时在晚上使用昂贵且朴实的医疗设备。 项目背景：OSA患者的主要医疗疗法需要使用医疗 设备（连续的正气道压力（CPAP）或口服电器）很难 患有轻度至中度疾病的患者每晚定期使用。因为大多数 这些患者经常停止使用这些疗法，他们继续增加 未经处理的OSA的后果。未经治疗和未经治疗的OSA继续更糟 增加年龄和体重，这仅使OSA后果的风险更加复杂。 OSA 后果包括增加一系列医疗合并症的风险（例如糖尿病，， 心血管疾病，耐药性高血压和抑郁症）以及障碍 白天由于白天的嗜睡过多而发挥作用，包括汽车增加或 工作场所事故，工作绩效障碍和离婚风险更高。口面 肌功能疗法（OMT）采用康复方法，并由等渗组合 以及针对口腔（例如舌头）和口咽的等距练习（例如，柔软的口感，以后 咽墙）。 项目目标：本研究的目的是检查口径肌膜功能的影响 在具有轻度至中度睡眠呼吸暂停的退伍军人中的治疗。要回答的主要问题是 OMT是否改善了OSA严重性，患者功能状态和OSA符号的测量值 与假OMT相比。 项目方法：我们提出了一项为期6个月的随机，受控，非盲人，单中心研究 与假的口语肌功能疗法相比，口服肌功能疗法（OMT）（假手术 OMT）。干预部门的参与者将接受3个月的活跃OMT干预措施，而 Sham Omt将提供没有练习和活动的建议 治疗功能或作用，包括一般呼吸运动，放松和拉伸 脖子和肩膀。研究的主要结果度量将是组间变化 OSA疾病严重程度的主要度量（呼吸暂停指数）。重要的次要目标将 专注于患者功能状态和OSA符号（例如，白天嗜睡和睡眠过多 质量）。 [主要研究时间点是3个月，而6个月的时间点将评估 治疗效果的持续时间。]