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

A

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Other: Expiratory muscle trainig

Study type

Interventional

Funder types

Other

Identifiers

NCT04454242
2020/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

19 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups

L-EMST
Experimental group
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.
Treatment:
Other: Expiratory muscle trainig
H-EMST
Active Comparator group
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.
Treatment:
Other: Expiratory muscle trainig

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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