Clinical trial NCT04454242: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Expiratory muscle strength training
Snoring
Sleep quality
EMST
Lead sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2020-07-01
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease severity
timeFrame: 2 day
measure: Respiratory muscle strength
timeFrame: 5 day
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: 2 day
measure: Snoring severitiy and frequency
timeFrame: 2 day
measure: Sleep quality
timeFrame: 2 day
measure: Fatigue severity.
timeFrame: 2 day
Other outcomes:
measure: Antropometric measurements
timeFrame: 2 day
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
affiliation: Hacettepe University
name: Ebru Calik-Kutukcu, PhD
role: STUDY_DIRECTOR
References: