Obstructive Sleep Apnea SyndromeNCT04454242
High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
A study testing Expiratory muscle trainig in people with Obstructive Sleep Apnea Syndrome, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Expiratory muscle trainig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Jun 2022
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
- General health condition is stable
Who cannot join
- Passed stroke,
- Neurological disease and psychological disease
- Cardiac disease
- Hypothyroidism
- Serious obstructive nasal disease,
- A history of infection in the past month.
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- Previous oroferengeal surgery history
- With a BMI of 40 kg / m2 or more,
- Using substance, alcohol, sedative and hypnotic drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Trabzon
About this study
Official title: Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.
Read the detailed description
Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving.
Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Expiratory muscle trainig
- Keywords
- Expiratory muscle strength training, Snoring, Sleep quality, EMST
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory muscle trainigOther
This exercise will be used to strengthen forced expiratory muscles.
| Study group | Role | What they receive |
|---|---|---|
| L-EMST | Experimental | At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths.
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement. Receives: Other: Expiratory muscle trainig |
| H-EMST | Active comparator | In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths.
Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement. Receives: Other: Expiratory muscle trainig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease severity
Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
Measured: 2 day
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Measured: 5 day
Secondary outcomes (4)
Daytime sleepiness
Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'
Measured: 2 day
Snoring severitiy and frequency
Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Measured: 2 day
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Measured: 2 day
Fatigue severity.
Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jun 2021
- Primary completion30 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
- Investigators
- Ebru Calik-Kutukcu, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454242
- Sponsor's protocol ID
- 2020/09
- Status last verified
- Jan 2022
- First submitted
- 26 Jun 2020
- Last updated
- 20 Dec 2022
- 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 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04454242
- Acronym / sponsor ID
- 2020/09
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Expiratory muscle strength training, Snoring, Sleep quality, EMST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ahi Evren Chest and Cardiovascular Surgery Education and Research HospitalUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 1 Jul 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 effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.
Detailed description
Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving.
Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-EMST | Experimental | Other: Expiratory muscle trainigAt 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement. |
| H-EMST | Active comparator | Other: Expiratory muscle trainigIn 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
- General health condition is stable
Key exclusion criteria (9 listed)
- Passed stroke,
- Neurological disease and psychological disease
- Cardiac disease
- Hypothyroidism
- Serious obstructive nasal disease,
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 |
|---|---|---|
| Expiratory muscle trainigThis exercise will be used to strengthen forced expiratory muscles. | Other | H-EMST, L-EMST |
Primary outcome
Disease severity
Time frame: 2 day
Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
Respiratory muscle strength
Time frame: 5 day
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
4 secondary outcomes
Daytime sleepiness
Time frame: 2 day
Snoring severitiy and frequency
Time frame: 2 day
Sleep quality
Time frame: 2 day
Fatigue severity.
Time frame: 2 day
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 20 Dec 2022.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Ebru Calik-Kutukcu, PhD study director
Hacettepe 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 Expiratory muscle trainig in people with Obstructive Sleep Apnea Syndrome, run by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital 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 2 inclusion and 9 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 20 Dec 2022. 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?
Disease severity (time frame: 2 day). The study lists 2 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 20 Dec 2022.