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临床试验/NCT06783998
NCT06783998Enrolling By Invitation不适用

Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome

Tarsus University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
150
试验地点
1
主要终点
Anthropometric measurement

研究概览

简要总结

OSAS is a disease characterized by repeated interruptions and restarts of breathing during sleep. Respiratory muscle sarcopenia is a condition in which the muscle strength of the diaphragm and other respiratory auxiliary muscles decreases, resulting in a decrease in breathing effort. Decreased respiratory effort is an important indicator of OSAS. Age, presence of chronic disease, and obesity increase the presence and severity of respiratory sarcopenia. If OSAS is left untreated, it leads to cardiovascular diseases, dementia, Alzheimer's and even death in early adulthood. In recent years, studies have shown that continuous positive airway pressure (CPAP), as well as healthy behavior development, preventive health and exercise measures, are important in the management of these diseases. There is no research in the literature on the evaluation of respiratory muscle sarcopenia in OSAS patients.

This study aims to evaluate respiratory muscle sarcopenia in OSAS based on a concrete value reflecting respiratory muscle strength and/or volume.

详细描述

In the study, respiratory muscle sarcopenia will be evaluated in OSAS patients. It will be evaluated whether the expiratory pressure value, peek flow meter value and 6-minute walking distance are predictors of respiratory sarcopenia for OSAS.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with normal-mild-medium-severe OSAS
  • •18 years and above
  • •Turkish speaking patients will be included.

排除标准

  • •Pregnancy,
  • •Latent autoimmune diabetes,
  • •Chronic renal failure,
  • •Active or serious infections,
  • •Liver failure,
  • •Recent major cardiovascular events,
  • •Unstable angina, heart failure (NYHA III-IV),
  • •Patients with neurological or musculoskeletal disorders that create limitations in walking and performing tests

结局指标

主要结局

Anthropometric measurement

时间窗: 1 year

Waist circumference, hip circumference will be measured, waist-hip ratio will be calculated.

BOdy mass measurement

时间窗: 1 year

Body weight,fat-free mass (FFM) and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass expressed in kilograms will be measured by bioelectrical impedance.

Hand Grip strength

时间窗: 1 year

Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and has been found to have high validity and reliability in many studies and is therefore considered the gold standard, will be used to measure hand grip strength.

Walking speed

时间窗: 1 year

Walking speed will be measured with the 4 Meter Walking Speed Test (4MYHT).

Respiratory muscle strength:

时间窗: 1 year

Respiratory muscle strength will be evaluated with a portable, electronic mouth pressure measurement device.

Expiratory flow rate

时间窗: 1 year

Peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR) and peak flow measurement, will be measured with a PEFmeter (MSA 100 PEFmeter), a small, hand-held device used to monitor a person's ability to breathe air.

Respiratory function test

时间窗: 1 year

To evaluate pulmonary functions(FEV1/FVC ve FEV1 ), it will be measured in a sitting position with a Spirolab III brand spirometer according to ATS/European Respiratory Society (ERS) criteria.

次要结局

  • Functional capacity(1 year)

研究者

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

Nurel Ertürk

Assist. Prof. PT. PhD Nurel Ertürk

Tarsus University

研究点 (1)

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