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

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疾病之一 退伍军人健康管理局 (VHA) 的条件。由于加大了诊断力度， 许多退伍军人管理局的睡眠计划现在遇到了更多被诊断患有轻度至 - 中度阻塞性睡眠呼吸暂停（OSA）。口面部肌功能治疗 (OMT) OSA 的康复方法，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且繁重的医疗设备。 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) 或口腔矫治器），这些设备对于 患有轻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，但他们的风险仍然增加 未经治疗的 OSA 的后果。未经治疗和治疗不足的 OSA 继续恶化 年龄和体重的增加只会增加 OSA 后果的风险。 OSA 后果包括一系列合并症的风险增加（例如糖尿病、 心血管疾病、难治性高血压和抑郁症）和损伤 由于白天过度嗜睡，包括因机动车辆或车辆而增加的白天功能 工作场所事故、工作表现受损以及更高的离婚风险。口面部 肌功能疗法 (OMT) 对 OSA 采用康复方法，包括等张疗法 针对口腔（例如舌头）和口咽部（例如软腭、侧肌）的等长练习 咽壁）。 项目目标：本研究的目的是检查口面部肌功能的效果 对患有轻度至中度睡眠呼吸暂停的退伍军人进行治疗。主要要回答的问题是 OMT 是否可以改善 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：我们提出一项为期 6 个月的随机、对照、非盲、单中心研究 口面部肌功能治疗 (OMT) 与假手术相比 口面部肌功能治疗（假手术） 奥姆特）。干预组的参与者将接受为期 3 个月的主动 OMT 干预，而干预组的参与者将接受为期 3 个月的积极 OMT 干预。 将向假 OMT 提供没有实际指导的锻炼和活动建议 治疗功能或效果，包括一般呼吸练习、放松和伸展身体 颈部和肩部。该研究的主要结果指标将是组间变化 OSA 疾病严重程度的主要指标（呼吸暂停-呼吸不足指数）。重要的次要目标将 关注患者的功能状态和 OSA 症状（例如，白天过度嗜睡和睡眠不足） 质量）。 [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。]

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.]