Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: respiratory muscle strengthening exercise; Other: oropharyngeal muscles strengthening exercise

• Registration Number: NCT04201236
• Lead Sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	respiratory muscle strengthening exercise	The inspiratory muscle training group was administered for 12 weeks starting from 30% of maximal oral pressure, 7 days a week, 15 minutes twice a day. Patients came to the control once a week, mouth pressures were measured and training pressure was adjusted in 30% of the new value.
Oropharyngeal exercises	oropharyngeal muscles strengthening exercise	Oropharyngeal exercises include soft palate, tongue and facial muscle exercises as well as stomatognathic function exercises. Training sessions were held once a day, 5 days a week for 12 weeks under the supervision of a mirror.

Primary Outcome Measures

Name	Time	Method
Polysomnography	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 Outcome Measures

Name	Time	Method
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device	6 day	Respiratory muscle strength
6 minute walk test	2 day	Exercise capacity
Epworth Sleepiness Scale	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'
Functional Outcomes of Sleep Questionnaire	2 day	Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life
Berlin Questionnaire	2 day	Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity
Fatigue Severity Scale	2 day	Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception
The Pittsburgh Sleep Quality Index	2 day	Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality

Trial Locations

Locations (1)

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital; 🇹🇷 Trabzon, Turkey