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Enrolling by Invitation

NCT Number: NCT06783998

Evaluation of Respiratory Muscle Sarcopenia in Obstructive Sleep Apnea Syndrome

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tarsus University

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Anthropometric measurement

    Time frame: 1 year

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

  2. 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.

  3. 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.

  4. Walking speed

    Time frame: 1 year

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

  5. Respiratory muscle strength:

    Time frame: 1 year

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

  6. 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.

  7. 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

  1. Functional capacity

    Time frame: 1 year

    Functional exercise capacity will be evaluated with the 6-minute walk test (6MWT)

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Acronym: RMS-OSAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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