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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Oxidative Stress; Respiratory Muscle Training
• Intervention / Treatment: Other: Expiratory muscle trainig

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon
    • Ortahi̇sar, Trabzon, Turkey, 61100
      • Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: H-EMST; 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; This exercise will be used to strengthen forced expiratory muscles.
Experimental: L-EMST; 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; This exercise will be used to strengthen forced expiratory muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	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 days
Maximal inspiratory and expiratory muscle strength	Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.	2 days
Daytime sleepiness	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'	2 days
Fatigue severity.	Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception	2 days
Sleep quality	The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.	2 days

Collaborators and Investigators

• Sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Collaborators: The Scientific and Technological Research Council of Turkey
• Investigators: Study Chair: 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; Principal Investigator: Nurel Erturk, MsC, Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital; Study Director: Ebru Çalık Kütükçü, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Oxidative Stress
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Inflammation; Apnea
• Other Study ID Numbers: 2021/363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No