Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome
January 19, 2022 updated by: Haluk TEKERLEK, Hacettepe University
Assessment Respiratory and Submental Muscles Activity During Inspiratory and Expiratory Maneuver in Patients With Obstructive Sleep Apnea Syndrome
In this study respiratory and submental muscle activities during during inspiratory and expiratory breathing maneuver at specific workloads will be assessed according to inspiratory and expiratory muscle strength of each obstructive sleep apnea syndrome (OSAS) patient's.
Study Overview
Status
Completed
Conditions
Detailed Description
Recurrent upper airway obstruction, apnea-hypopnea events, arousals and asphyxia during sleep increase the respiratory workload in patients with OSAS.
This results in chronic overload of the inspiratory muscles -especially the diaphragm- and respiratory muscle fatigue in OSAS.
When the literature was checked, there was no study assessing and comparing the activities of M. genioglossus, submental muscles (upper airways dilator muscles) and diaphragm during inspiration and expiration in a workload.
Differences in the activity of these muscles according to the type of respiratory maneuver will provide more appropriate respiratory muscle training in patients.
Study Type
Observational
Enrollment (Actual)
20
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
-
-
-
Ankara, Turkey
- Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation
-
-
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
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with OSAS who will be referred to the Cardiopulmonary Rehabilitation Unit of the Faculty of Physical Therapy and Rehabilitation of Hacettepe University by Dışkapı Yıldırım Beyazıt Educational and Research Hospital Department of Chest Diseases will be included in this study.
Description
Inclusion Criteria:
- Between 35-70 years old
- Diagnosed with mild-moderate OSAS
- Clinically stabile
Exclusion Criteria:
- Anatomical obstructive upper airway
- Occupations that lead to sleep deprivation or alterations in the sleep-wake cycle.
- Comorbidities such as chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases and psychiatric diseases
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Study group
The patient with OSAS 35-70 years of age, clinically stabile, symptoms such as snoring, breathing cessations, and daytime sleepiness, and polysomnographic evidence consistent with mild (5<apnea hypopnea index (AHI)< 15) to moderate (16 < AHI < 30) OSAS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary function test
Time Frame: about thirty minutes
|
Pulmonary function will be assessed with a portable spirometer thorough the standard procedures.
Pulmonary function test results will be recorded during the inspiratory and expiratory maneuver.
|
about thirty minutes
|
|
Respiratory muscle strength
Time Frame: about thirty minutes
|
Respiratory muscle strength will be measured with a respiratory pressure meter.
Maximal inspiratory pressure and expiratory pressure were recorded.
|
about thirty minutes
|
|
Surface electromyographic (sEMG) measurement of submental muscles and diaphragm
Time Frame: about thirty minutes
|
Surface electromyographic (sEMG) activity of the submental muscle group (including the anterior belly of the digastric, mylohyoid, geniohyoid, and platysmas) and diaphragm will be measured during inspiratory and expiratory maneuver.
|
about thirty minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haluk Tekerlek, MSc, Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 16, 2019
Primary Completion (Actual)
September 14, 2021
Study Completion (Actual)
December 14, 2021
Study Registration Dates
First Submitted
September 21, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Actual)
January 20, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- osasemg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.