Evaluation of Inspiratory Muscle Strength in Patients With Multiple System Atrophy
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|ClinicalTrials.gov Identifier: NCT04287270|
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple System Atrophy||Other: Assesment||Not Applicable|
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; determine whether sniff nasal inspiratory pressure (SNIP) measurement is a useful method for assessing respiratory muscle strength in multisystem atrophy patients and correlate it with standard maximal inspiratory mouth pressure measurement.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multiple system atrophyAtrophy patients; Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Pulmonary function test will be performed.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparison of Two Different Methods in the Evaluation of Inspiratory Muscle Strength in Patients With Multiple System Atrophy|
|Actual Study Start Date :||February 2, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Assesment of MSA patients
Demographic information (sex, age, occupation, height, bodyweight ...), clinical and medical status, diagnosis date and Mini-Mental Status Scale data of all participants will be recorded at the first visit. Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure and maximal inspiratory mouth pressure. Also, the pulmonary function test will be applied.
Evaluations which explained in the arms section will be made as described.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287270
|Contact: Semra Oguz, PT, PhDfirstname.lastname@example.org|
|Marmara University Faculty of Health Sciences||Recruiting|
|Istanbul, Maltepe, Turkey|
|Contact: Semra Oguz, PT, PhD +905327143424 email@example.com|
|Study Director:||Semra Oguz, PT, PhD||Marmara University|
|Principal Investigator:||Begum Unlu, PT, MSc||Marmara University|