Skip to main content
Clinical Trials/NCT04858399
NCT04858399
Completed
Not Applicable

Examination of Orofacial Muscles With Myotonometer in Obstructive Sleep Apnea Syndrome and Investigation of the Risk of Exposure According to Disease Severity

Bitlis Eren University1 site in 1 country80 target enrollmentApril 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea Syndromes
Sponsor
Bitlis Eren University
Enrollment
80
Locations
1
Primary Endpoint
The muscle tone evaluation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.

Detailed Description

Obstructive sleep apnea (OSA) syndrome is a common but often unrecognized disorder caused by pharyngeal collapse during sleep and characterized by frequent awakenings, disrupted sleep, and consequent excessive daytime sleepiness. Upper airway resistance increase during sleep and upper airway inspiratory muscle activity decrease especially during bursts of rapid eye movements in REM (Rapid Eye-Movements) sleep. In this study, the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome will be investigated. The project is planned to be carried out with participants who applied to the Bitlis State Hospital Chest Diseases Clinic and were diagnosed with OSA by polysomnography and other diagnostic methods. Based on "the Apnea-Hypopnea Index OSA rating scoring for adult individuals", participants will be divided into three groups: mild, moderate, and severe OSA. Healthy participants will form the fourth group on the control level. The respiratory functions of the participants will be evaluated with spirometry and a standard application procedure will be used. With the MyotonPro device, the tone of the orofacial muscles (m. digastricus venter anterior and m. mylohyoideus, tongue and m. masseter, m. temporalis) will be evaluated and data transferred to the computer will be reported. In the muscle tonus evaluations, standardization in cervical positioning will be provided by a dual digital inclinometer. The Hospital Anxiety and Depression Scale (HAD) will be used to evaluate the anxiety/depression levels of the participants, and the Short Form-36 (SF-36), which is prescribed as the global gold standard, will be used in the assessment of the quality of life. MyotonPro reliability investigation will be done by two separate researchers. The researchers will perform measurements independently, at the baseline, and after 1 week. MyotonPro evaluations will be based on anatomical localization points. During the measurement, both researchers will use the standard positioning protocol at both evaluation times.

Registry
clinicaltrials.gov
Start Date
April 21, 2021
End Date
December 30, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bitlis Eren University
Responsible Party
Principal Investigator
Principal Investigator

Tülay Çevik Saldıran

PT, Assistant Professor

Bitlis Eren University

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years old.
  • Getting a diagnosis of OSAS with polysomnography.
  • Agree to participate in the study.

Exclusion Criteria

  • Having respiratory system disease (COPD, asthma, bronchiectasis, lung cancer, etc.).
  • Sedative, hypnotic drug intake. Use of medical supplements such as diazepam.
  • Hypothyroidism, acromegaly.
  • Diagnosis of a psychiatric illness.
  • Uncontrolled arrhythmia causing symptoms or hemodynamic impairment.
  • Pulmonary edema.
  • Pregnancy

Outcomes

Primary Outcomes

The muscle tone evaluation

Time Frame: Day 1.

MyotonPro device will be used for muscle tone evaluation.The device provides a controlled preload of 0.18 N for initial compression of the subcutaneous tissue and then release an additional 15-ms impulse of 0.40 N of mechanical force, which induces a damped or decaying natural oscillation of the tissue35. The calculation formula was as follows: S = amax. mprobe/Δl; amax - maximum amplitude of the oscillation in the acceleration signal; mprobe - mass (preload) of the probe of 0.18 N, Δl - amplitude of the displacement signal.

Secondary Outcomes

  • Evaluation of the anxiety and depression.(Day 1.)

Study Sites (1)

Loading locations...

Similar Trials