We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Muscle Tone Change in Obstructive Sleep Apnea (OSASMumecPRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04858399
Recruitment Status : Completed
First Posted : April 26, 2021
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Tülay Çevik Saldıran, Bitlis Eren University

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.

Condition or disease Intervention/treatment
Sleep Apnea Syndromes Diagnostic Test: Evaluation

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Examination of Orofacial Muscles With Myotonometer in Obstructive Sleep Apnea Syndrome and Investigation of the Risk of Exposure According to Disease Severity
Actual Study Start Date : April 21, 2021
Actual Primary Completion Date : September 18, 2021
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Sleep Apnea

Group/Cohort Intervention/treatment
Mild Severity OSAS
Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour.
Diagnostic Test: Evaluation
To examine 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.

Moderate Severity OSAS
Moderate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour.
Diagnostic Test: Evaluation
To examine 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.

High Severity OSAS
Severe sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour
Diagnostic Test: Evaluation
To examine 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of the anxiety and depression. [ Time Frame: Day 1. ]
    The Hospital Anxiety and Depression Scale will be used to evaluate the anxiety/depression levels of the participants. It consists of two subscales, one measuring anxiety, with seven items, and one measuring depression, with seven items, which are scored separately. Each item was answered by the patient on a 4-point (0 - 3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. It takes 2 - 5 min to complete.


Other Outcome Measures:
  1. Evaluation of Quality of Life [ Time Frame: Day 1. ]
    The Short Form-36 will be used to evaluate the quality of life of patients. This 36-item, self-administered generic health profile questionnaire provides summary scores in two domains, physical health, and mental health.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic in Bitlis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858399


Locations
Layout table for location information
Turkey
Bitlis State Hospital
Bitlis, Turkey, 13000
Sponsors and Collaborators
Bitlis Eren University
Layout table for additonal information
Responsible Party: Tülay Çevik Saldıran, PT, Assistant Professor, Bitlis Eren University
ClinicalTrials.gov Identifier: NCT04858399    
Other Study ID Numbers: BEU_2
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tülay Çevik Saldıran, Bitlis Eren University:
Muscle Tone
Quality of Life
Depression
Respiration
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases