Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome

NCT06783998 | Enrolling By Invitation

• 1 other identifier: 2025/01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSAS)

Keywords

Obstruktive sleep apnea; sarcopenia; respiratory muscle

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Functional capacity

  1 year

Study Arms (1)

OSAS

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

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sarcopenia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. PT. PhD Nurel Ertürk

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 20, 2025
• Study Start: May 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)