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

Obstructive Sleep Apnea Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242406
• Other study ID #: 2021/363
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Inflammation
• Obstructive Sleep Apnea
• Oxidative Stress
• Respiratory Muscle Training
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Expiratory muscle trainig
This exercise will be used to strengthen forced expiratory muscles.

Locations

Country	Name	City	State
Turkey	Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital	Ortahi?sar	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Systemic inflammation-1	CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.	5 days
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Maximal inspiratory and expiratory muscle strength	Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.	2 days
Secondary	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
Secondary	Fatigue severity.	Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception	2 days
Secondary	Sleep quality	The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.	2 days