- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465874
Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea Syndrome
Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea: A Polysomnography-Based Methodological Study
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder characterized by recurrent upper airway obstruction during sleep, leading to intermittent hypoxia and sleep fragmentation. In addition to its well-known cardiometabolic consequences, OSA may negatively affect functional capacity and daily activity performance. However, upper extremity functional capacity in individuals with OSA has not been adequately evaluated.
The 6-Minute Pegboard and Ring Test (6PBRT) is a functional test designed to assess upper extremity functional capacity during unsupported arm activity. Although the test has been widely used in respiratory diseases, its measurement properties have not yet been evaluated in patients with OSA.
The aim of this study is to investigate the validity and reliability of the 6PBRT in adults diagnosed with obstructive sleep apnea using polysomnography. Participants with OSA will undergo polysomnographic evaluation and complete the 6PBRT. Test-retest reliability will be assessed by repeating the test under the same conditions. The relationship between 6PBRT performance and polysomnographic parameters (AHI, ODI, minimum SpO₂ and T90) will also be examined. In addition, associations between 6PBRT performance and clinical scales such as the Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire will be analyzed.
The findings of this study are expected to provide evidence regarding the measurement properties of the 6PBRT in individuals with OSA and contribute to the clinical assessment of upper extremity functional capacity in this population.
Study Overview
Status
Conditions
Detailed Description
Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep resulting in intermittent hypoxia, sleep fragmentation, and increased sympathetic activity. These physiological disturbances may negatively affect physical performance, daily functioning, and exercise tolerance. Although previous studies have investigated balance, gait, and overall physical performance in individuals with OSA, upper extremity functional capacity has received limited attention.
The 6-Minute Pegboard and Ring Test (6PBRT) is a functional performance test that evaluates upper extremity endurance during unsupported arm activity. The test has been used primarily in patients with chronic respiratory diseases to assess functional limitation during activities involving arm elevation. However, the validity and reliability of the 6PBRT have not been investigated in individuals with OSA.
This observational methodological study aims to evaluate the validity and reliability of the 6PBRT in adults diagnosed with OSA using polysomnography. Participants diagnosed with OSA will be recruited from the sleep center of Mardin Training and Research Hospital. Demographic and clinical data including age, sex, body mass index, and comorbidities will be recorded. Polysomnographic parameters including apnea-hypopnea index (AHI), oxygen desaturation index (ODI), minimum oxygen saturation (SpO₂), and the percentage of sleep time with oxygen saturation below 90% (T90) will be collected from medical records.
Upper extremity functional capacity will be assessed using the 6PBRT. Participants will perform the test according to standardized procedures. Test-retest reliability will be evaluated by repeating the test under similar conditions. In addition, clinical scales including the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) will be administered.
The validity of the 6PBRT will be investigated by examining its relationship with polysomnographic parameters and clinical scales. Reliability will be evaluated using test-retest analysis and intraclass correlation coefficients. The results of this study will provide important information regarding the measurement properties of the 6PBRT in individuals with OSA and may support its use as a practical tool for assessing upper extremity functional capacity in clinical practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: engin ramazanoğlu, Assistant Professor
- Phone Number: +905334889447
- Email: enginramazanoglu@artuklu.edu.tr
Study Locations
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Mardin
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Mardin, Mardin, Turkey (Türkiye), 47510
- Mardin Artuklu University
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Contact:
- Funda Mete Cavus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between 18 and 65 years of age
Having a diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography
Having sufficient cognitive ability to understand and follow the test instructions
Having adequate shoulder range of motion to elevate the upper extremities above head level for performing the 6PBRT
Voluntarily agreeing to participate in the study and providing written informed consent
Exclusion Criteria:
- Presence of neurological diseases that may significantly affect upper extremity function (e.g., stroke, multiple sclerosis, peripheral neuropathy)
Severe orthopedic conditions limiting upper extremity movement (e.g., advanced shoulder pathology, recent surgery, severe contracture)
Unstable cardiopulmonary conditions (e.g., recent myocardial infarction, decompensated heart failure, uncontrolled arrhythmia, acute COPD/asthma exacerbation)
Acute infection, febrile illness, or severe clinical exacerbation within the last 4 weeks
Pain severe enough to interfere with the test or any clinical condition preventing the safe administration of the test
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Mild Obstructive Sleep Apnea
Adults diagnosed with mild obstructive sleep apnea based on polysomnography (Apnea-Hypopnea Index 5-14 events/hour).
Participants will undergo assessment of upper extremity functional capacity using the 6-Minute Pegboard and Ring Test (6PBRT).
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Moderate Obstructive Sleep Apnea
Adults diagnosed with moderate obstructive sleep apnea according to polysomnography findings (Apnea-Hypopnea Index 15-29 events/hour).
Participants will perform the 6-Minute Pegboard and Ring Test to assess upper extremity functional capacity.
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Severe Obstructive Sleep Apnea
Adults diagnosed with severe obstructive sleep apnea based on polysomnography (Apnea-Hypopnea Index ≥30 events/hour).
Upper extremity functional capacity will be evaluated using the 6-Minute Pegboard and Ring Test.
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Healthy Control
Age- and sex-matched healthy individuals without a diagnosis of obstructive sleep apnea.
Participants will undergo assessment of upper extremity functional capacity using the 6-Minute Pegboard and Ring Test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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6-Minute Pegboard and Ring Test (6PBRT) Score
Time Frame: Baseline
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Upper extremity functional capacity assessed using the 6-Minute Pegboard and Ring Test.
The outcome will be the total number of rings moved during the 6-minute test.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test-Retest Reliability of the 6PBRT
Time Frame: Within 7 days
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Reliability of the 6PBRT will be evaluated by repeating the test under the same conditions and calculating intraclass correlation coefficients.
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Within 7 days
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Hand Grip Strength
Time Frame: Baseline
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Hand grip strength will be measured using a hand dynamometer to evaluate upper extremity muscle strength.
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Baseline
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Functional Outcomes of Sleep Questionnaire (FOSQ)
Time Frame: Baseline
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Sleep-related functional status will be assessed using the Functional Outcomes of Sleep Questionnaire.
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Baseline
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Epworth Sleepiness Scale (ESS)
Time Frame: Baseline
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Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (score range 0-24).
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Baseline
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Polysomnography Parameters
Time Frame: Baseline
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Relationship between 6PBRT performance and polysomnographic parameters including Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), minimum oxygen saturation (SpO₂), and percentage of sleep time with oxygen saturation below 90% (T90).
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Baseline
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Fatigue Severity Scale (FSS)
Time Frame: Baseline
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Fatigue severity will be assessed using the Fatigue Severity Scale (score range 1-7).
Higher scores indicate greater fatigue severity.
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ben Saad H, Ben Hassen I, Ghannouchi I, Latiri I, Rouatbi S, Escourrou P, Ben Salem H, Benzarti M, Abdelghani A. 6-Min walk-test data in severe obstructive-sleep-apnea-hypopnea-syndrome (OSAHS) under continuous-positive-airway-pressure (CPAP) treatment. Respir Med. 2015 May;109(5):642-55. doi: 10.1016/j.rmed.2015.03.001. Epub 2015 Mar 16.
- Szentkiralyi A, Madarasz CZ, Novak M. Sleep disorders: impact on daytime functioning and quality of life. Expert Rev Pharmacoecon Outcomes Res. 2009 Feb;9(1):49-64. doi: 10.1586/14737167.9.1.49.
- Iannella G,Pace A,Bellizzi MG,Magliulo G,Greco A,De Virgilio A,Croce E,Gioacchini FM,Re M,Costantino A,Casale M,Moffa A,Lechien JR,Cocuzza S,Vicini C,Caranti A,Marchese Aragona R,Lentini M,Maniaci A
- Kang YJ,Park CS
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/2-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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