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临床试验/NCT04608552
NCT04608552已完成不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2021年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
209
试验地点
2
主要终点
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

研究概览

简要总结

The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. 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) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild-to-moderate OSA
  • Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
  • Confirmed diagnosis of OSA
  • Having chronic symptoms per screening symptom checklist
  • Fluency in English
  • Must be getting care the VA San Diego Healthcare System

排除标准

  • Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
  • Low health literacy
  • Residence in a geographical area outside of San Diego County
  • Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
  • Significant documented substance/chemical abuse

结局指标

主要结局

Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)

时间窗: 3 months and 6 months

Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.

次要结局

  • Change in Epworth Sleepiness Score (ESS; measure of sleepiness)(3 months and 6 months)
  • Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)(3 months and 6 months)
  • Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)(3 months and 6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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