Skip to main content
OpenTrials
Completed

NCT Number: NCT04201236

Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year–75 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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

*To be diagnosed with mild, moderate and severe OSAS.

Exclusion criteria

  • Patients with a history of stroke,
  • neurological disease,
  • severe obstructive nasal disease,
  • and infection in the last month,
  • BMI being 40 kg /m2 or more.

Treatment and study plan

respiratory muscle strengthening exercise

Other

These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.

oropharyngeal muscles strengthening exercise

Other

These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .

Primary outcomes

  1. Polysomnography

    Time frame: 2 day

    Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity

Secondary outcomes

  1. Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device

    Time frame: 6 day

    Respiratory muscle strength

  2. 6 minute walk test

    Time frame: 2 day

    Exercise capacity

  3. Epworth Sleepiness Scale

    Time frame: 2 day

    minimum and maximum scores: 0-24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'

  4. Berlin Questionnaire

    Time frame: 2 day

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

  5. Functional Outcomes of Sleep Questionnaire

    Time frame: 2 day

    Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life

  6. The Pittsburgh Sleep Quality Index

    Time frame: 2 day

    Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality

  7. Fatigue Severity Scale

    Time frame: 2 day

    Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception

Sponsors and collaborators

Lead sponsor

Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Other

Registry information

Official study title

Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2019
Registry last updated
Dec 18, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.