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High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04454242
Enrollment
32
Registered
2020-07-01
Start date
2021-06-01
Completion date
2022-06-01
Last updated
2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Expiratory muscle strength training, Snoring, Sleep quality, EMST

Brief 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. 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.

Interventions

This exercise will be used to strengthen forced expiratory muscles.

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included. 2. General health condition is stable

Exclusion criteria

1. Passed stroke, 2. Neurological disease and psychological disease 3. Cardiac disease 4. Hypothyroidism 5. Serious obstructive nasal disease, 6. A history of infection in the past month. 7. Previous oroferengeal surgery history 8. With a BMI of 40 kg / m2 or more, 9. Using substance, alcohol, sedative and hypnotic drugs

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strength5 dayMaximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Disease severity2 dayPolysomnography 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

Secondary

MeasureTime frameDescription
Snoring severitiy and frequency2 dayBerlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Fatigue severity.2 dayFatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Sleep quality2 dayThe Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Daytime sleepiness2 dayEpworth 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'

Other

MeasureTime frameDescription
Antropometric measurements2 dayNeck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026