search
Back to results

Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
respiratory muscle strengthening exercise
oropharyngeal muscles strengthening exercise
Sponsored by
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, oropharyngeal exercises, inspiratory muscle training, sleep quality

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Oropharyngeal exercises

Inspiratory muscle training

Control

Arm Description

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.

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.

This group was only monitorized without any rehabilitation intervention.

Outcomes

Primary Outcome Measures

Polysomnography
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

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

Full Information

First Posted
December 13, 2019
Last Updated
December 17, 2019
Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04201236
Brief Title
Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea
Official Title
Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, oropharyngeal exercises, inspiratory muscle training, sleep quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oropharyngeal exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group was only monitorized without any rehabilitation intervention.
Intervention Type
Other
Intervention Name(s)
respiratory muscle strengthening exercise
Intervention Description
These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.
Intervention Type
Other
Intervention Name(s)
oropharyngeal muscles strengthening exercise
Intervention Description
These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .
Primary Outcome Measure Information:
Title
Polysomnography
Description
Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity
Time Frame
2 day
Secondary Outcome Measure Information:
Title
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Description
Respiratory muscle strength
Time Frame
6 day
Title
6 minute walk test
Description
Exercise capacity
Time Frame
2 day
Title
Epworth Sleepiness Scale
Description
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'
Time Frame
2 day
Title
Berlin Questionnaire
Description
Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity
Time Frame
2 day
Title
Functional Outcomes of Sleep Questionnaire
Description
Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life
Time Frame
2 day
Title
The Pittsburgh Sleep Quality Index
Description
Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality
Time Frame
2 day
Title
Fatigue Severity Scale
Description
Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception
Time Frame
2 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adem Celik, MD
Organizational Affiliation
Ahi Evren Thoracic and Cardiovascular Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
City
Trabzon
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

We'll reach out to this number within 24 hrs