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Trial record 3 of 100 for:    "Brain Diseases" AND "Multiple System Atrophy"

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
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
The purpose of this study is; determine whether sniff nasal inspiratory pressure (SNIP) measurement is a useful method for assessing respiratory muscle strength in multiple system atrophy patients and correlate it with standard maximal inspiratory mouth pressure measurement.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Other: Assesment Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Assesment
Evaluations which explained in the arms section will be made as described.




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Semra Oguz, PT, PhD +905327143424 ptsemraoguz@gmail.com

Locations
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Turkey
Marmara University Faculty of Health Sciences Recruiting
Istanbul, Maltepe, Turkey
Contact: Semra Oguz, PT, PhD    +905327143424    ptsemraoguz@gmail.com   
Sponsors and Collaborators
Marmara University
Investigators
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Study Director: Semra Oguz, PT, PhD Marmara University
Principal Investigator: Begum Unlu, PT, MSc Marmara University

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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04287270    
Other Study ID Numbers: SAG-B-241018-0566
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
Multiple System Atrophy
Respiratory Muscle Strength
Sniff Nasal Inspiratory Pressure
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Respiratory Aspiration
Atrophy
Pathological Conditions, Anatomical
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases