Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 10:49 AM
Study NCT ID:
NCT05242406
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS
Sponsor:
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Secondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: