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Clinical Trials/NCT06783998
NCT06783998Enrolling By InvitationNot Applicable

Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome

Tarsus University1 site in 1 country150 target enrollmentStarted: May 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Anthropometric measurement

Study Overview

Brief Summary

OSAS is a disease characterized by repeated interruptions and restarts of breathing during sleep. Respiratory muscle sarcopenia is a condition in which the muscle strength of the diaphragm and other respiratory auxiliary muscles decreases, resulting in a decrease in breathing effort. Decreased respiratory effort is an important indicator of OSAS. Age, presence of chronic disease, and obesity increase the presence and severity of respiratory sarcopenia. If OSAS is left untreated, it leads to cardiovascular diseases, dementia, Alzheimer's and even death in early adulthood. In recent years, studies have shown that continuous positive airway pressure (CPAP), as well as healthy behavior development, preventive health and exercise measures, are important in the management of these diseases. There is no research in the literature on the evaluation of respiratory muscle sarcopenia in OSAS patients.

This study aims to evaluate respiratory muscle sarcopenia in OSAS based on a concrete value reflecting respiratory muscle strength and/or volume.

Detailed Description

In the study, respiratory muscle sarcopenia will be evaluated in OSAS patients. It will be evaluated whether the expiratory pressure value, peek flow meter value and 6-minute walking distance are predictors of respiratory sarcopenia for OSAS.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with normal-mild-medium-severe OSAS
  • •18 years and above
  • •Turkish speaking patients will be included.

Exclusion Criteria

  • •Pregnancy,
  • •Latent autoimmune diabetes,
  • •Chronic renal failure,
  • •Active or serious infections,
  • •Liver failure,
  • •Recent major cardiovascular events,
  • •Unstable angina, heart failure (NYHA III-IV),
  • •Patients with neurological or musculoskeletal disorders that create limitations in walking and performing tests

Outcomes

Primary Outcomes

Anthropometric measurement

Time Frame: 1 year

Waist circumference, hip circumference will be measured, waist-hip ratio will be calculated.

BOdy mass measurement

Time Frame: 1 year

Body weight,fat-free mass (FFM) and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass expressed in kilograms will be measured by bioelectrical impedance.

Hand Grip strength

Time Frame: 1 year

Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and has been found to have high validity and reliability in many studies and is therefore considered the gold standard, will be used to measure hand grip strength.

Walking speed

Time Frame: 1 year

Walking speed will be measured with the 4 Meter Walking Speed Test (4MYHT).

Respiratory muscle strength:

Time Frame: 1 year

Respiratory muscle strength will be evaluated with a portable, electronic mouth pressure measurement device.

Expiratory flow rate

Time Frame: 1 year

Peak expiratory flow (PEF), also called peak expiratory flow rate (PEFR) and peak flow measurement, will be measured with a PEFmeter (MSA 100 PEFmeter), a small, hand-held device used to monitor a person's ability to breathe air.

Respiratory function test

Time Frame: 1 year

To evaluate pulmonary functions(FEV1/FVC ve FEV1 ), it will be measured in a sitting position with a Spirolab III brand spirometer according to ATS/European Respiratory Society (ERS) criteria.

Secondary Outcomes

  • Functional capacity(1 year)

Investigators

Sponsor
Tarsus University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nurel Ertürk

Assist. Prof. PT. PhD Nurel Ertürk

Tarsus University

Study Sites (1)

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