- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07913139
Functional Capacity in Obstructive Sleep Apnea
Investigation of Functional Capacity in Patients With Obstructive Sleep Apnea
Obstructive sleep apnea syndrome (OSAS) is a condition characterized by a deterioration in respiratory function and an increase in the activity of accessory respiratory muscles. This condition can affect patients' use of their upper extremities during daily living activities. In this context, our study aimed to examine respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, upper extremity functional exercise capacity, muscle oxygenation, and dyspnea in patients with OSAS, and to compare these parameters with those of healthy controls.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Musa Güneş, PhD
- Phone Number: 03704789131
- Email: musagunes@karabuk.edu.tr
Study Locations
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Karabük, Turkey (Türkiye)
- Recruiting
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
-
Contact:
- Musa Güneş, MsC
- Phone Number: 03704189081
- Email: musagunes@karabuk.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Individuals with a diagnosis of Obstructive Sleep Apnea Syndromeand healthy individuals will be included in the study.
Description
Inclusion Criteria:
- Aged 18-65,
- Diagnosis of Obstructive Sleep Apnea Syndrome (OSAS) confirmed by a pulmonologist following polysomnography,
- An Apnea-Hypopnea Index (AHI) ≥5 for OSAS,
- Willingness to participate in the study.
Exclusion Criteria:
- Having severe orthopedic, neurological, or cardiac conditions,
- Having a diagnosed pulmonary disease,
- Having a history of-or currently experiencing-a psychiatric or neurological disorder,
- Not being willing to participate in the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_CONTROL
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
|---|
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Obstructive sleep apnea
Patients with obstructive sleep apnea syndrome will be included in the study. |
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Control Group
Healthy individuals will be included in the study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Upper extremity exercise capacity
Time Frame: Baseline
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Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). |
Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary function (Forced vital capacity (FVC)
Time Frame: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured. |
Baseline
|
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Pulmonary function (Forced expiratory volume in the first second (FEV1)
Time Frame: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured. |
Baseline
|
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Pulmonary function (FEV1 / FVC)
Time Frame: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured. |
Baseline
|
|
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time Frame: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured. |
Baseline
|
|
Pulmonary function (Peak flow rate (PEF))
Time Frame: Baseline
|
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured. |
Baseline
|
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Peripheral muscle strength
Time Frame: Baseline
|
Peripheral muscle strength will be evaluated with a dynamometer. |
Baseline
|
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Respiratory Muscle Strength
Time Frame: Baseline
|
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated. |
Baseline
|
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Respiratory Muscle Endurance
Time Frame: Baseline
|
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. |
Baseline
|
|
Muscle oxygenation
Time Frame: Baseline
|
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). |
Baseline
|
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Dyspnea
Time Frame: Baseline
|
Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia Hande Avcı, MD, Karabuk University
- Study Director: Musa Güneş, PhD, Karabuk University
- Principal Investigator: Ebrar Tülümenoğlu, MSc (c), Karabuk University
- Principal Investigator: Nisa Nur Dönmez, MSc (c), Karabuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk_OUAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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