Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

December 17, 2019 updated by: NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
Time Frame: 6 day
Respiratory muscle strength
6 day
6 minute walk test
Time Frame: 2 day
Exercise capacity
2 day
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'
2 day
Berlin Questionnaire
Time Frame: 2 day
Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity
2 day
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
2 day
The Pittsburgh Sleep Quality Index
Time Frame: 2 day
Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality
2 day
Fatigue Severity Scale
Time Frame: 2 day
Fatigue severity. Minimum and maximum scores: 0-7. Scores higher than 4 shows high intensity fatigue perception
2 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Adem Celik, MD, Ahi Evren Thoracic and Cardiovascular Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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