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

NCT05242406 | Completed

• 1 other identifier: 2021/363
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Oxidative Stress; Respiratory Muscle Training

Keywords

Obstructive Sleep Apnea; Oxidative Stress

Outcome Measures

Primary Outcomes (7)

• 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

  2 days

• Oxidative stress-1

  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.

  5 days

• Systemic inflammation-1

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

  5 days

• Systemic inflammation-2

  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 days

• Systemic inflammation-3

  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.

  5 days

• Systemic inflammation-4

  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.

  5 days

• Oxidative stress-2

  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.

  5 days

Secondary Outcomes (5)

• Exercise capacity

  2 days

• Maximal inspiratory and expiratory muscle strength

  2 days

• Daytime sleepiness

  2 days

• Fatigue severity.

  2 days

• Sleep quality

  2 days

Study Arms (2)

H-EMST

EXPERIMENTAL

In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 12 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

L-EMST

EXPERIMENTAL

At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 12 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

Interventions

Expiratory muscle trainig OTHER

This exercise will be used to strengthen forced expiratory muscles.

H-EMST; L-EMST

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital: lead

Study Sites (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Ortahi̇sar, Trabzon, 61100, Turkey (Türkiye)

Location

Related Publications (1)

• Erturk N, Celik A, Kahraman Yaman S, Yaman H, Unal F, Calik Kutukcu E. Expiratory muscle strength training reduces oxidative stress and systemic inflammation in men with obstructive sleep apnea syndrome: a double-blinded, randomized parallel trial. Sleep. 2024 Dec 11;47(12):zsae221. doi: 10.1093/sleep/zsae221.

  PMID: 39297486 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Adem Çelik, MD

  Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

  STUDY CHAIR

• Sevim Kahraman Yaman, MD

  Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

  STUDY CHAIR

• Hüseyin Yaman, MD

  Karadeniz Technical University

  STUDY CHAIR

• Nurel Erturk, MsC

  Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ebru Çalık Kütükçü, PhD

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 16, 2022
• Study Start: June 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)