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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05242406
Other study ID # 2021/363
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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