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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454242
• Other study ID #: 2020/09
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2022
• Source: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• Expiratory muscle trainig
This exercise will be used to strengthen forced expiratory muscles.

Locations

Country	Name	City	State
Turkey	Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital	Trabzon

Sponsors (2)

Lead Sponsor	Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antropometric measurements	Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method	2 day
Primary	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	2 day
Primary	Respiratory muscle strength	Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device	5 day
Secondary	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'	2 day
Secondary	Snoring severitiy and frequency	Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.	2 day
Secondary	Sleep quality	The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.	2 day
Secondary	Fatigue severity.	Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception	2 day