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NCT Number: NCT04287270

Respiratoy Muscle Strength in Patients With Multiple System Atrophy

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • dementia
  • Nasal congestion

Treatment and study plan

Assesment

Other

Evaluations which explained in the arms section will be made as described.

Primary outcomes

  1. Maximal inspiratory mouth pressure (PImax)

    Time frame: 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.

  2. Sniff nasal inspiratory pressure (SNIP)

    Time frame: 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.

  3. Maximal expiratory mouth pressure (PEmax)

    Time frame: 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.

Secondary outcomes

  1. Forced vital capacity (FVC)

    Time frame: 15 minutes

    Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters. FVC is the most basic maneuver in spirometry tests. Pulmonary function test is performed to determine FVC.

  2. Forced expiratory volume in 1 second (FEV1)

    Time frame: 15 minutes

    Forced expiratory volume in 1 second (FEV1) is the volume of air that can forcibly be blown out in first 1 second, after full inspiration. Pulmonary function test is performed to determine FEV1.

  3. FEV1/FVC

    Time frame: 15 minutes

    FEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% (declining with age).

  4. Peak expiratory flow (PEF)

    Time frame: 15 minutes

    Peak expiratory flow (PEF) is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration, measured in liters per minute or in liters per second. Pulmonary function test is performed to determine PEF.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Respiratory Muscle Strength in Patients With Multiple System Atrophy

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 27, 2020
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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