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NCT Number: NCT04454242

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Snoring

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expiratory muscle trainig

Other

This exercise will be used to strengthen forced expiratory muscles.

Primary outcomes

  1. Disease severity

    Time frame: 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

  2. Respiratory muscle strength

    Time frame: 5 day

    Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

Secondary outcomes

  1. Daytime sleepiness

    Time frame: 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'

  2. Snoring severitiy and frequency

    Time frame: 2 day

    Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity.

  3. Sleep quality

    Time frame: 2 day

    The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.

  4. Fatigue severity.

    Time frame: 2 day

    Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception

Other outcomes

  1. Antropometric measurements

    Time frame: 2 day

    Neck circumference, Waist circumference, Hip circumference, Waist to hip ratio with circumference measurement method

Sponsors and collaborators

Lead sponsor

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2020
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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