Multiple System AtrophyNCT04287270
Respiratoy Muscle Strength in Patients With Multiple System Atrophy
A study testing Assesment in people with Multiple System Atrophy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Assesment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2019to 26 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Health Sciences
Istanbul, Maltepe
About this study
Official title: Evaluation of Respiratory 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.
Read the 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; 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).
- Conditions
- Multiple System Atrophy
- Being tested
- Assesment
- Keywords
- Multiple System Atrophy, Respiratory Muscle Strength, Sniff Nasal Inspiratory Pressure
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
Evaluations which explained in the arms section will be made as described.
| Study group | Role | What they receive |
|---|---|---|
| Assesment of MSA patients and healthy controls | Other | 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, expiratory muscle strength will be evaluated with expiratory mouth pressure. Also, the pulmonary function test will be applied. Receives: Other: Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory mouth pressure (PImax)
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.
Measured: 15 minutes
Sniff nasal inspiratory pressure (SNIP)
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.
Measured: 10 minutes
Maximal expiratory mouth pressure (PEmax)
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.
Measured: 15 minutes
Secondary outcomes (4)
Forced vital capacity (FVC)
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.
Measured: 15 minutes
Forced expiratory volume in 1 second (FEV1)
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.
Measured: 15 minutes
FEV1/FVC
FEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% (declining with age).
Measured: 15 minutes
Peak expiratory flow (PEF)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Feb 2019
- Primary completion1 Jul 2020
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple system atrophy patients; Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed. Healthy Controls: Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Semra Oguz, PT, PhD, Study director, Marmara UniversityBegum Unlu, PT, MSc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287270
- Sponsor's protocol ID
- SAG-B-241018-0566
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Muscle Strength in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT04287270
- Acronym / sponsor ID
- SAG-B-241018-0566
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy, Respiratory Muscle Strength, Sniff Nasal Inspiratory Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple system atrophy patients; Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed. Healthy Controls: Inspiratory muscle strength will be evaluated with sniff nasal inspiratory pressure (SNIP) and maximal inspiratory mouth pressure (PImax). Expiratory muscle strength will be evaluated maximal expiratory mouth pressure (PEmax). Pulmonary function test will be performed.
| Arm | Type | Receives |
|---|---|---|
| Assesment of MSA patients and healthy controls | Other | Other: AssesmentDemographic 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, expiratory muscle strength will be evaluated with expiratory mouth pressure. Also, the pulmonary function test will be applied. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssesmentEvaluations which explained in the arms section will be made as described. | Other | Assesment of MSA patients and healthy controls |
Primary outcome
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.
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.
4 secondary outcomes
Forced vital capacity (FVC)
Time frame: 15 minutes
Forced expiratory volume in 1 second (FEV1)
Time frame: 15 minutes
FEV1/FVC
Time frame: 15 minutes
Peak expiratory flow (PEF)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semra Oguz, PT, PhD study director
Marmara University
Begum Unlu, PT, MSc principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assesment in people with Multiple System Atrophy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory mouth pressure (PImax) (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.