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临床试验/NCT04287270
NCT04287270已完成不适用

Evaluation of Respiratory Muscle Strength in Patients With Multiple System Atrophy

Marmara University2 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2019年2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
19
试验地点
2
主要终点
Maximal inspiratory mouth pressure (PImax)

研究概览

简要总结

The purpose of this study is; compare respiratory function parameters and respiratory muscle strength in patients with MSA compare to healthy controls, and to evaluate the results of SNIP and PImax in measuring inspiratory muscle strength in MSA patients.

详细描述

Multiple system atrophy (MSA) is a sporadic, neurodegenerative disease that begins in adulthood, progressive, unexplained. Brain stem degeneration is thought to play a role in respiratory symptoms such as stridor, sleep-related respiratory disturbances and respiratory failure in MSA patients. Respiratory disorders were emphasized and evaluated in MSA during the studies. However, the pattern of pulmonary anomalies or the performance of the inspiratory muscles is not well defined in the MSA.

Inspiratory muscle strength is assessed by voluntary or involuntary tests. The most commonly used reference values are the known maximal inspiratory mouth pressure (PImax) measurement for ease of use. In people with neuromuscular disease, the influence of the orofacial muscles can cause air leakage from the mouth. As a result, low values may be due to air escape which caused by true respiratory muscle weakness, submaximal effort or weakness of the facial muscles.

The purpose of this study is; compare respiratory function parameters and respiratory muscle strength in patients with MSA compare to healthy controls, and to evaluate the results of SNIP and MIP in measuring inspiratory muscle strength in MSA patients.

For this purpose; demographic information (sex, age, occupation, height, body weight ...), clinical and medical status, diagnosis date and Mini Mental Status Scale data of all participants will be recorded at the visit. Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure and maximal inspiratory mouth pressure. Expiratory muscle strength will be evaluated with maximal expiratory mouth pressure (PEmax).

研究设计

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

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between 40-80 years old
  • Have been diagnosed with MSA
  • Being under drug treatment
  • Being enlightened to participate in the study and filling in the consent form
  • Respiratory disease or no history of occupational exposure to affect the respiratory system
  • The absence of any physical or mental disability that will prevent the implementation of the tests
  • Mini Mental Test score> 24

排除标准

  • Any history of neuromuscular disease other than MSA
  • Having a diagnosis of psychiatric illness
  • Chronic obstructive pulmonary disease (COPD) diagnosis
  • The patient is not cooperative
  • Nasal congestion

结局指标

主要结局

Maximal inspiratory mouth pressure (PImax)

时间窗: 15 minutes

Maximum inspiratory pressure (PImax) is the classic volitional test of inspiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum inspiratory effort against a quasi occlusion. Evaluation is carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.

Sniff nasal inspiratory pressure (SNIP)

时间窗: 10 minutes

Sniff nasal inspiratory pressure (SNIP) measurement is a volitional noninvasive assessment of inspiratory muscle strength. A maximum of 10 sniffs is generally used. It is a simple procedure consisting of measuring peak nasal pressure (cmH2O) as a result of maximal sniff performance through from the end of expiration with the open nostril while the other one is closed.

Maximal expiratory mouth pressure (PEmax)

时间窗: 15 minutes

Maximum expiratory pressure (PEmax) is the classic volitional test of expiratory muscle strength. It is measured as the highest mouth pressure (cmH2O) sustained for 1 s during a maximum expiratory effort against a quasi occlusion. Evaluation is carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.

次要结局

  • FEV1/FVC(15 minutes)
  • Forced vital capacity (FVC)(15 minutes)
  • Forced expiratory volume in 1 second (FEV1)(15 minutes)
  • Peak expiratory flow (PEF)(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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