An interventional study of Expiratory muscle trainig in Obstructive Sleep Apnea Syndrome, sponsored by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 32 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Expiratory muscle trainig
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.
Other: Expiratory muscle trainig
This exercise will be used to strengthen forced expiratory muscles.
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
Time frame: 2 day
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Time frame: 5 day
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'
Time frame: 2 day
Snoring severitiy and frequency
Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Time frame: 2 day
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Time frame: 2 day
Fatigue severity.
Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Time frame: 2 day
Antropometric measurements
Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method
Time frame: 2 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital