Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201236
• Other study ID #: 2019/11
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: December 2019
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• respiratory muscle strengthening exercise
These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.
• oropharyngeal muscles strengthening exercise
These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity	2 day
Secondary	Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device	Respiratory muscle strength	6 day
Secondary	6 minute walk test	Exercise capacity	2 day
Secondary	Epworth Sleepiness Scale	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'	2 day
Secondary	Berlin Questionnaire	Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity	2 day
Secondary	Functional Outcomes of Sleep Questionnaire	Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life	2 day
Secondary	The Pittsburgh Sleep Quality Index	Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality	2 day
Secondary	Fatigue Severity Scale	Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception	2 day