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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Disease severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients diagnosed with moderate OSAS by polysomnography in the Sleep Center of Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital,
- •Those who are between 19-60 years old,
- •Stable general health status,
- •Volunteer to participate in the research,
- •Not using NIMV device,
- •Patients who do not have a mental problem that will prevent cooperation will be included.
Exclusion Criteria
- •Female gender,
- •Having a previous stroke,
- •Having an overlap syndrome,
- •Having any neurological, psychological or cardiac disease,
- •Uncontrolled hypertension and high blood glucose levels,
- •Severe obstructive nasal disease,
- •History of previous oropharyngeal surgery
- •Having a body mass index of 40 kg/m2 or more,
- •Using drugs, alcohol, sedative and hypnotic drugs,
- •Having a cognitive problem
Outcomes
Primary Outcomes
Disease severity
Time Frame: 2 days
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
Oxidative stress-1
Time Frame: 5 days
TAS: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-1
Time Frame: 5 days
CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.
Systemic inflammation-3
Time Frame: 5 days
IL10: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-4
Time Frame: 5 days
IL-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.
Systemic inflammation-2
Time Frame: 5 days
TNF-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.
Oxidative stress-2
Time Frame: 5 days
TOS: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.
Secondary Outcomes
- Daytime sleepiness(2 days)
- Exercise capacity(2 days)
- Maximal inspiratory and expiratory muscle strength(2 days)
- Fatigue severity.(2 days)
- Sleep quality(2 days)
Investigators
NUREL ERTURK
Principal Investigator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital