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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Other: Expiratory muscle trainig

• Registration Number: NCT04454242
• Lead Sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2021-06-01
• Status Verified: 2022-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H-EMST	Expiratory muscle trainig	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.
L-EMST	Expiratory muscle trainig	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.

Primary Outcome Measures

Name	Time	Method
Disease severity	2 day	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	5 day	Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

Secondary Outcome Measures

Name	Time	Method
Snoring severitiy and frequency	2 day	Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.
Fatigue severity.	2 day	Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception
Daytime sleepiness	2 day	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'
Sleep quality	2 day	The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.

Trial Locations

Locations (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital; 🇹🇷 Trabzon, Turkey