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

NCT ID: NCT05242406

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-04-01

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Oxidative Stress Respiratory Muscle Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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H-EMST

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.

Group Type EXPERIMENTAL

Expiratory muscle trainig

Intervention Type OTHER

This exercise will be used to strengthen forced expiratory muscles.

L-EMST

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.

Group Type EXPERIMENTAL

Expiratory muscle trainig

Intervention Type OTHER

This exercise will be used to strengthen forced expiratory muscles.

Interventions

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Expiratory muscle trainig

This exercise will be used to strengthen forced expiratory muscles.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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NUREL ERTURK

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adem Çelik, MD

Role: STUDY_CHAIR

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Sevim Kahraman Yaman, MD

Role: STUDY_CHAIR

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Hüseyin Yaman, MD

Role: STUDY_CHAIR

Karadeniz Technical University

Nurel Erturk, MsC

Role: PRINCIPAL_INVESTIGATOR

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Ebru Çalık Kütükçü, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Ortahi̇sar, Trabzon, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Erturk N, Celik A, Kahraman Yaman S, Yaman H, Unal F, Calik Kutukcu E. Expiratory muscle strength training reduces oxidative stress and systemic inflammation in men with obstructive sleep apnea syndrome: a double-blinded, randomized parallel trial. Sleep. 2024 Dec 11;47(12):zsae221. doi: 10.1093/sleep/zsae221.

Reference Type DERIVED
PMID: 39297486 (View on PubMed)

Other Identifiers

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2021/363

Identifier Type: -

Identifier Source: org_study_id

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