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临床试验/NCT04858399
NCT04858399已完成不适用

Examination of Orofacial Muscles With Myotonometer in Obstructive Sleep Apnea Syndrome and Investigation of the Risk of Exposure According to Disease Severity

Bitlis Eren University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The muscle tone evaluation

研究概览

简要总结

The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.

详细描述

Obstructive sleep apnea (OSA) syndrome is a common but often unrecognized disorder caused by pharyngeal collapse during sleep and characterized by frequent awakenings, disrupted sleep, and consequent excessive daytime sleepiness. Upper airway resistance increase during sleep and upper airway inspiratory muscle activity decrease especially during bursts of rapid eye movements in REM (Rapid Eye-Movements) sleep. In this study, the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome will be investigated. The project is planned to be carried out with participants who applied to the Bitlis State Hospital Chest Diseases Clinic and were diagnosed with OSA by polysomnography and other diagnostic methods. Based on "the Apnea-Hypopnea Index OSA rating scoring for adult individuals", participants will be divided into three groups: mild, moderate, and severe OSA. Healthy participants will form the fourth group on the control level. The respiratory functions of the participants will be evaluated with spirometry and a standard application procedure will be used. With the MyotonPro device, the tone of the orofacial muscles (m. digastricus venter anterior and m. mylohyoideus, tongue and m. masseter, m. temporalis) will be evaluated and data transferred to the computer will be reported. In the muscle tonus evaluations, standardization in cervical positioning will be provided by a dual digital inclinometer. The Hospital Anxiety and Depression Scale (HAD) will be used to evaluate the anxiety/depression levels of the participants, and the Short Form-36 (SF-36), which is prescribed as the global gold standard, will be used in the assessment of the quality of life. MyotonPro reliability investigation will be done by two separate researchers. The researchers will perform measurements independently, at the baseline, and after 1 week. MyotonPro evaluations will be based on anatomical localization points. During the measurement, both researchers will use the standard positioning protocol at both evaluation times.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old.
  • Getting a diagnosis of OSAS with polysomnography.
  • Agree to participate in the study.

排除标准

  • Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
  • Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
  • Hypothyroidism, acromegaly.
  • Diagnosis of a psychiatric illness.
  • Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
  • Pulmonary edema.
  • Pregnancy

结局指标

主要结局

The muscle tone evaluation

时间窗: Day 1.

MyotonPro device will be used for muscle tone evaluation.The device provides a controlled preload of 0.18 N for initial compression of the subcutaneous tissue and then release an additional 15-ms impulse of 0.40 N of mechanical force, which induces a damped or decaying natural oscillation of the tissue35. The calculation formula was as follows: S = amax. mprobe/Δl; amax - maximum amplitude of the oscillation in the acceleration signal; mprobe - mass (preload) of the probe of 0.18 N, Δl - amplitude of the displacement signal.

次要结局

  • Evaluation of the anxiety and depression.(Day 1.)

研究者

发起方
Bitlis Eren University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tülay Çevik Saldıran

PT, Assistant Professor

Bitlis Eren University

研究点 (1)

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