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

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.

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

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.
Observational

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.
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

  • Turkey
      • 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

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

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.
  • 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.

General Publications

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.
September 16, 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.
September 14, 2021

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.
December 14, 2021

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).
September 21, 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.
September 23, 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.
September 25, 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.
January 20, 2022

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.
January 19, 2022

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.
January 1, 2022

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.
  • 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.

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