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NCT Number: NCT05242406

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Oxidative Stress Respiration Disorders Respiratory Muscle Training Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Ortahi̇sar, Trabzon, 61100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expiratory muscle trainig

Other

This exercise will be used to strengthen forced expiratory muscles.

Primary outcomes

  1. 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

  2. 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.

  3. Systemic inflammation-1

    Time frame: 5 days

    CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. Exercise capacity

    Time frame: 2 days

    6 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.

  2. Maximal inspiratory and expiratory muscle strength

    Time frame: 2 days

    Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.

  3. Daytime sleepiness

    Time frame: 2 days

    Epworth 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'

  4. Fatigue severity.

    Time frame: 2 days

    Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception

  5. Sleep quality

    Time frame: 2 days

    The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.

Sponsors and collaborators

Lead sponsor

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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