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

A

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Status

Completed

Conditions

Respiratory Muscle Training
Oxidative Stress
Obstructive Sleep Apnea

Treatments

Other: Expiratory muscle trainig

Study type

Interventional

Funder types

Other

Identifiers

NCT05242406
2021/363

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

Male

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

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,
  1. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

H-EMST
Experimental group
Description:
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.
Treatment:
Other: Expiratory muscle trainig
L-EMST
Experimental group
Description:
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.
Treatment:
Other: Expiratory muscle trainig

Trial contacts and locations

1

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Central trial contact

Ebru Çalık Kütükcü, PhD; Nurel Erturk, MsC

Data sourced from clinicaltrials.gov

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