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Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS

Investigation of the Effect of Expiratory Muscle Strength Training Applied at Different Intensities on Systemic Inflammation and Oxidative Stress in Patients With Moderate Obstructive Sleep Apnea Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05242406
Enrollment
31
Registered
2022-02-16
Start date
2022-06-01
Completion date
2023-04-01
Last updated
2023-08-14

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

Conditions

Obstructive Sleep Apnea, Oxidative Stress, Respiratory Muscle Training

Keywords

Obstructive Sleep Apnea, Oxidative Stress

Brief summary

It was aimed to investigate the effect of expiratory muscle strength training (EMST) applied at different intensities on systemic inflammation and oxidative stress in patients with moderate obstructive sleep apnea syndrome (OSAS). In the study, 32 male patients diagnosed with moderate OSAS will be included in the study. Participants will then be divided into 2 groups by block randomization. In the three-blind planned study; the first group will receive high-intensity %60 maximum expiratory pressure (MEP) EMST training, and the second group will be given low-intensity 30% of MEP, EMST training for 12 weeks. Disease-related symptoms, disease severity apnea-hypopnea index (AHI), oxidative stress index (OSI) and systemic inflammation level, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and fatigue severity will be evaluated before and after the study.

Detailed description

Primary outcome measures are; disease severity, oxidative stress index and systemic inflammation. Secondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.

Interventions

This exercise will be used to strengthen forced expiratory muscles.

Sponsors

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

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

Inclusion criteria

1. Male patients diagnosed with moderate OSAS by polysomnography in the Sleep Center of Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, 2. Those who are between 19-60 years old, 3. Stable general health status, 4. Volunteer to participate in the research, 5. Not using NIMV device, 5\) Patients who do not have a mental problem that will prevent cooperation will be included.

Exclusion criteria

1. Female gender, 2. Having a previous stroke, 3. Having an overlap syndrome, 4. Having any neurological, psychological or cardiac disease, 5. Uncontrolled hypertension and high blood glucose levels, 6. Severe obstructive nasal disease, 7. History of previous oropharyngeal surgery 8. Having a body mass index of 40 kg/m2 or more, 9. Using drugs, alcohol, sedative and hypnotic drugs, 10. Having a cognitive problem

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress-25 daysTOS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit.
Oxidative stress-15 daysTAS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit.
Systemic inflammation-15 daysCRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.
Systemic inflammation-25 daysTNF-a:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.
Systemic inflammation-35 daysIL10:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.
Systemic inflammation-45 daysIL-6:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.
Disease severity2 daysPolysomnography 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
Maximal inspiratory and expiratory muscle strength2 daysMaximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.
Daytime sleepiness2 daysEpworth Sleepiness Scale . Minimum and maximum scores: 0-24. The higher Epworth Sleepiness Scale score means the higher that person's average sleep propensity in daily life , or their 'daytime sleepiness'
Fatigue severity.2 daysFatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Sleep quality2 daysThe Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Exercise capacity2 days6 minute walking testing (6MWT):The primary outcome is the distance covered in meters or converted measure (such as feet) over 6 minutes. To measure functional aerobic capacity or general fitness, this test may be used in conjunction with VO2 testing.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026