Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: oropharyngeal muscles strengthening exercise; Other: respiratory muscle strengthening exercise

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey
    • Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oropharyngeal exercises; 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.	Other: oropharyngeal muscles strengthening exercise; These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .
Experimental: Inspiratory muscle training; 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.	Other: respiratory muscle strengthening exercise; These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.
No Intervention: Control; This group was only monitorized without any rehabilitation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Investigators: Study Chair: Adem Celik, MD, Ahi Evren Thoracic and Cardiovascular Surgery Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; inspiratory muscle training; sleep quality; oropharyngeal exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Apnea
• Other Study ID Numbers: 2019/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No