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High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Primary Purpose

Obstructive Sleep Apnea Syndrome

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 Syndrome focused on measuring Expiratory muscle strength training, Snoring, Sleep quality, EMST

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included.
  2. General health condition is stable

Exclusion Criteria:

  1. Passed stroke,
  2. Neurological disease and psychological disease
  3. Cardiac disease
  4. Hypothyroidism
  5. Serious obstructive nasal disease,
  6. A history of infection in the past month.
  7. Previous oroferengeal surgery history
  8. With a BMI of 40 kg / m2 or more,
  9. Using substance, alcohol, sedative and hypnotic drugs

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-EMST

H-EMST

Arm Description

At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 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.

In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 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.

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
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

Secondary Outcome Measures

Daytime sleepiness
Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'
Snoring severitiy and frequency
Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.
Fatigue severity.
Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception

Full Information

First Posted
June 26, 2020
Last Updated
December 19, 2022
Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT04454242
Brief Title
High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
Official Title
Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 1, 2022 (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
Collaborators
The Scientific and Technological Research Council of Turkey

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
The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.
Detailed Description
Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving. Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Expiratory muscle strength training, Snoring, Sleep quality, EMST

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

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 8 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.
Arm Title
H-EMST
Arm Type
Active Comparator
Arm Description
In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 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.
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 day
Title
Respiratory muscle strength
Description
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Time Frame
5 day
Secondary Outcome Measure Information:
Title
Daytime sleepiness
Description
Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'
Time Frame
2 day
Title
Snoring severitiy and frequency
Description
Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Time Frame
2 day
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 day
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 day
Other Pre-specified Outcome Measures:
Title
Antropometric measurements
Description
Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method
Time Frame
2 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included. General health condition is stable Exclusion Criteria: Passed stroke, Neurological disease and psychological disease Cardiac disease Hypothyroidism Serious obstructive nasal disease, A history of infection in the past month. Previous oroferengeal surgery history With a BMI of 40 kg / m2 or more, Using substance, alcohol, sedative and hypnotic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Calik-Kutukcu, 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
Trabzon
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

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