Clinical trial NCT05242406: Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Oxidative Stress
Respiratory Muscle Training
Keywords: Obstructive Sleep Apnea
Oxidative Stress
Lead sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 31
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease severity
timeFrame: 2 days
measure: Oxidative stress-1
timeFrame: 5 days
measure: Systemic inflammation-1
timeFrame: 5 days
measure: Systemic inflammation-2
timeFrame: 5 days
measure: Systemic inflammation-3
timeFrame: 5 days
measure: Systemic inflammation-4
timeFrame: 5 days
measure: Oxidative stress-2
timeFrame: 5 days
Secondary outcomes:
measure: Exercise capacity
timeFrame: 2 days
measure: Maximal inspiratory and expiratory muscle strength
timeFrame: 2 days
measure: Daytime sleepiness
timeFrame: 2 days
measure: Fatigue severity.
timeFrame: 2 days
measure: Sleep quality
timeFrame: 2 days
Other outcomes:
Locations:
city: Ortahi̇sar
country: Turkey
facility: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
state: Trabzon
Study officials:
affiliation: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Adem Çelik, MD
role: STUDY_CHAIR
affiliation: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Sevim Kahraman Yaman, MD
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Hüseyin Yaman, MD
role: STUDY_CHAIR
affiliation: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Nurel Erturk, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Çalık Kütükçü, PhD
role: STUDY_DIRECTOR
References: