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: 10508506
• 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/10508506
• 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.]

对退伍军人医疗保健的预期影响：睡眠呼吸暂停是最常见的慢性 退伍军人健康管理局（VHA）。由于加大了诊断力度， 许多退伍军人管理局的睡眠项目现在遇到了更高水平的退伍军人被诊断为轻度至 中度阻塞性睡眠呼吸暂停（OSA）。口面肌功能治疗（OMT）需要一个 OSA的康复方法，并可为VHA患者和提供者提供治疗选择 这不需要在晚上睡觉时使用昂贵和繁重的医疗设备。 项目背景：OSA患者的主要药物治疗需要使用药物 设备（持续气道正压通气（CPAP）或口腔器具），这是困难的， 轻度至中度疾病患者每晚定期使用。因为大多数 这些患者经常停止使用这些疗法，他们继续处于增加的风险中， 未治疗OSA的后果未治疗和治疗不足的OSA继续恶化， 增加年龄和体重，这只会增加OSA后果的风险。OSA 结果包括一系列医学合并症的风险增加（例如，糖尿病、 心血管疾病、难治性高血压和抑郁症）和 由于白天过度嗜睡导致的白天功能，包括机动车或 工伤事故、工作表现受损以及离婚风险增加。口面 肌功能治疗（OMT）采用康复方法治疗OSA， 以及针对口腔的等长锻炼（例如，舌）和口咽（例如，外侧软腭 咽壁）。 项目目的：本研究的目的是检查口面肌功能的影响， 轻度至中度睡眠呼吸暂停退伍军人的治疗。要回答的主要问题是 OMT是否改善OSA严重程度、患者功能状态和OSA症状的测量 与假OMT相比。 项目方法：我们提出了一项为期6个月的随机、对照、非盲、单中心研究， 口面肌功能治疗（OMT）与假口面肌功能治疗（假 OMT）。干预组的参与者将接受3个月的主动OMT干预， 假OMT将提供建议的行使和活动，没有一个 治疗功能或效果，包括一般的呼吸练习，放松和伸展的 脖子和肩膀。本研究的主要结局指标将是组间变化， OSA疾病严重程度的主要指标（呼吸暂停低通气指数）。重要的次要目标将 关注患者功能状态和OSA症状（例如，白天过度嗜睡和睡眠 质量）。[The主要研究时间点为3个月，而6个月时间点将评估 治疗效果的持续时间]。