Muscle Tone Change in Obstructive Sleep Apnea

NCT04858399 | Completed

• 1 other identifier: BEU_2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

Muscle Tone; Quality of Life; Depression; Respiration

Outcome Measures

Primary Outcomes (1)

• The muscle tone evaluation

  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.

  Day 1.

Secondary Outcomes (1)

• Evaluation of the anxiety and depression.

  Day 1.

Other Outcomes (1)

• Evaluation of Quality of Life

  Day 1.

Study Arms (3)

Mild Severity OSAS

Mild sleep apnea: An Apnea-Hypopnea Index (AHI) of five to 14 events per hour.

Diagnostic Test: Evaluation

Moderate Severity OSAS

Moderate sleep apnea: An Apnea-Hypopnea Index (AHI) of 15 to 29 events per hour.

Diagnostic Test: Evaluation

High Severity OSAS

Severe sleep apnea: An Apnea-Hypopnea Index (AHI) of 30 or more events per hour

Diagnostic Test: Evaluation

Interventions

Evaluation DIAGNOSTIC_TEST

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; Mild Severity OSAS; Moderate Severity OSAS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic in Bitlis.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis State Hospital

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Depression; Respiratory Aspiration

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Assistant Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: April 21, 2021
• Primary Completion: September 18, 2021
• Study Completion: December 30, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

TU (1)