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临床试验/NCT05432908
NCT05432908终止不适用

Effect of Orofacial Myofunctional Therapy on Unintentional Air Leak From the Oral Cavity in Patients With Obstructive Sleep Apnea Treated With Continuous Positive Upper Airway Pressure (CPAP)

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Effect of Orofacial Myofunctional Therapy on mouth air leak

研究概览

简要总结

To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.

详细描述

The use of continuous positive airway pressure (CPAP) with a nasal mask during sleep is the gold standard treatment for moderate to severe obstructive sleep apnea (OSA). However, low adherence to CPAP is the main limiting factor in clinical practice. Recent studies suggest that unintentional air leak through the mouth contributes significantly to poor adherence to CPAP. Orofacial myofunctional therapy (OMT) is effective for treating mild to moderate OSA and has not been tested in patients with mouth air leaks. OSA patients using nasal CPAP and mouth air leaks will be recruited and will use the standard CPAP model and nasal mask during the first and last week of the study to record adherence and home leak. Patients will be treated by performing daily (3 times a day) orofacial myofunctional exercises aimed at strengthening the muscles of the oral cavity. Exercises will be supervised weekly for 3 months. All patients will undergo at the beginning and end of treatment: polysomnography with CPAP and nasal mask, speech-language pathology assessment adequated for OSA (scores ranging from 0 to 241, with higher values indicating greater dysfunction), quality of life questionnaire, and nasosinusal symptoms (SNOT -22), sleep quality (Pittsburgh) and sleepiness (Epworth). Polysomnography will include a pneumotachograph (Hans Rudolph) in the CPAP circuit to record flow and a magnetic jaw movement sensor (Brizzy) to record the episodes of mouth opening. The mouth air leak episodes were considered when they exceeded 20% above baseline (intentional leak with the mask fitted and mouth closed at the beginning of the PSG examination with CPAP) for a minimum of 10 seconds. Leaks ending with arousal or full awakening were considered arousal or full awakening associated with mouth air leak. Mouth opening during the leak episodes was determined by the difference between the amplitude at the end of the leak and the amplitude during the leak. Our hypothesis is that the orofacial myofunctional therapy will reduce mouth leakage in OSA patients treated with CPAP and nasal mask.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of OSA (AHI>15 events/h) on use of CPAP (>3 months) with suspect mouth leak as observed by the complaint of morning dry mouth and or CPAP report indicating an excessive air leak

排除标准

  • Central Sleep Apnea, oxygen dependent, COPD.

结局指标

主要结局

Effect of Orofacial Myofunctional Therapy on mouth air leak

时间窗: 3 months

The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy

次要结局

  • Effect of Orofacial Myofunctional Therapy on the adherence to CPAP(3 months)
  • Effect of Orofacial Myofunctional Therapy on the leak in CPAP report(3 months)
  • Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score(3 months)
  • Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geraldo Lorenzi Filho

Principal Investigator

University of Sao Paulo General Hospital

研究点 (2)

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