Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome (RMS-OSAS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obstructive Sleep Apnea (OSAS)

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Turkey
  • Mersi̇n
    • Mersin, Mersi̇n, Turkey
      • Tarsus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with normal-mild-medium-severe Obstructive Sleep Apnea Syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OSAS; Turkish-speaking patients diagnosed with normal-mild-moderate-severe OSAS, aged 18 and over, will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurement	Waist circumference, hip circumference will be measured, waist-hip ratio will be calculated.	1 year
BOdy mass measurement	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.	1 year
Hand Grip strength	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.	1 year
Walking speed	Walking speed will be measured with the 4 Meter Walking Speed Test (4MYHT).	1 year
Respiratory muscle strength:	Respiratory muscle strength will be evaluated with a portable, electronic mouth pressure measurement device.	1 year
Expiratory flow rate	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.	1 year
Respiratory function test	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Functional exercise capacity will be evaluated with the 6-minute walk test (6MWT)	1 year

Collaborators and Investigators

• Sponsor: Tarsus University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 24, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; respiratory muscle; Obstruktive sleep apnea
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Muscular Atrophy; Atrophy; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Sarcopenia
• Other Study ID Numbers: 2025/01

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
• product manufactured in and exported from the U.S.: No