search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea, Oxidative Stress, Respiratory Muscle Training

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Expiratory muscle trainig
Sponsored by
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Oxidative Stress

Eligibility Criteria

19 Years - 60 Years (Adult)MaleDoes not accept 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,

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

Sites / Locations

  • Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

H-EMST

L-EMST

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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.
Systemic inflammation-1
CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.
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.
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.
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.
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.

Secondary Outcome Measures

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.
Maximal inspiratory and expiratory muscle strength
Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.
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'
Fatigue severity.
Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.

Full Information

First Posted
January 12, 2022
Last Updated
August 9, 2023
Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05242406
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Oxidative Stress, Respiratory Muscle Training
Keywords
Obstructive Sleep Apnea, Oxidative Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H-EMST
Arm Type
Experimental
Arm 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.
Arm Title
L-EMST
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Expiratory muscle trainig
Intervention Description
This exercise will be used to strengthen forced expiratory muscles.
Primary Outcome Measure Information:
Title
Disease severity
Description
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
Time Frame
2 days
Title
Oxidative stress-1
Description
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.
Time Frame
5 days
Title
Systemic inflammation-1
Description
CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.
Time Frame
5 days
Title
Systemic inflammation-2
Description
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.
Time Frame
5 days
Title
Systemic inflammation-3
Description
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.
Time Frame
5 days
Title
Systemic inflammation-4
Description
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.
Time Frame
5 days
Title
Oxidative stress-2
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Exercise capacity
Description
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.
Time Frame
2 days
Title
Maximal inspiratory and expiratory muscle strength
Description
Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.
Time Frame
2 days
Title
Daytime sleepiness
Description
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'
Time Frame
2 days
Title
Fatigue severity.
Description
Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Time Frame
2 days
Title
Sleep quality
Description
The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Time Frame
2 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients diagnosed with moderate OSAS by polysomnography in the Sleep Center of Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, Those who are between 19-60 years old, Stable general health status, Volunteer to participate in the research, Not using NIMV device, 5) Patients who do not have a mental problem that will prevent cooperation will be included. Exclusion Criteria: Female gender, Having a previous stroke, Having an overlap syndrome, Having any neurological, psychological or cardiac disease, Uncontrolled hypertension and high blood glucose levels, Severe obstructive nasal disease, History of previous oropharyngeal surgery Having a body mass index of 40 kg/m2 or more, Using drugs, alcohol, sedative and hypnotic drugs, Having a cognitive problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adem Çelik, MD
Organizational Affiliation
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sevim Kahraman Yaman, MD
Organizational Affiliation
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hüseyin Yaman, MD
Organizational Affiliation
Karadeniz Technical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nurel Erturk, MsC
Organizational Affiliation
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebru Çalık Kütükçü, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
City
Ortahi̇sar
State/Province
Trabzon
ZIP/Postal Code
61100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs