Obstructive Sleep ApneaNCT07465874
Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea Syndrome
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults diagnosed with obstructive sleep apnea based on polysomnography who are followed in the Sleep Center of Mardin Training and Research Hospital will be included in the study. Participants will be classified into mild, moderate, and severe obstructive sleep apnea groups according to the apnea-hypopnea index (AHI). In addition, age- and sex-matched healthy individuals without obstructive sleep apnea will be recruited as a control group.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Artuklu University
Mardin, Mardin, 47510
Funda Mete Cavus
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Keywords
- 6-Minute Pegboard and Ring Test, Upper Extremity Functional Capacity, Polysomnography, Obstructive Sleep Apnea, Functional Performance
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). | |
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Pegboard and Ring Test (6PBRT) Score
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.
Measured: Baseline
Secondary outcomes (6)
Test-Retest Reliability of the 6PBRT
Reliability of the 6PBRT will be evaluated by repeating the test under the same conditions and calculating intraclass correlation coefficients.
Measured: Within 7 days
Hand Grip Strength
Hand grip strength will be measured using a hand dynamometer to evaluate upper extremity muscle strength.
Measured: Baseline
Functional Outcomes of Sleep Questionnaire (FOSQ)
Sleep-related functional status will be assessed using the Functional Outcomes of Sleep Questionnaire.
Measured: Baseline
Epworth Sleepiness Scale (ESS)
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (score range 0-24).
Measured: Baseline
Polysomnography Parameters
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).
Measured: Baseline
Fatigue Severity Scale (FSS)
Fatigue severity will be assessed using the Fatigue Severity Scale (score range 1-7). Higher scores indicate greater fatigue severity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion29 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465874
- Sponsor's protocol ID
- 2026/2-9
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be publicly shared to protect participant confidentiality. Only aggregated and anonymized results will be reported in scientific publications.
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.
PubMed 25820157Szentkiralyi 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.
PubMed 19371179Iannella 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. The Global Burden of Obstructive Sleep Apnea. Diagnostics (Basel). 2025 Apr 25;15(9):1088. doi: 10.3390/diagnostics15091088.
PubMed 40361906Kang YJ, Park CS. Mechanisms and Management of Obstructive Sleep Apnea: A Translational Overview. Clin Exp Otorhinolaryngol. 2025 Nov;18(4):296-305. doi: 10.21053/ceo.2025-00071. Epub 2025 Jun 2.
PubMed 40452394
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 6-Minute Pegboard and Ring Test (6PBRT) in Adults With Obstructive Sleep Apnea: A Polysomnography-Based Methodological Study
- ClinicalTrials.gov ID
- NCT07465874
- Acronym / sponsor ID
- 2026/2-9
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Keywords
- 6-Minute Pegboard and Ring Test, Upper Extremity Functional Capacity, Polysomnography, Obstructive Sleep Apnea, Functional Performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with obstructive sleep apnea based on polysomnography who are followed in the Sleep Center of Mardin Training and Research Hospital will be included in the study. Participants will be classified into mild, moderate, and severe obstructive sleep apnea groups according to the apnea-hypopnea index (AHI). In addition, age- and sex-matched healthy individuals without obstructive sleep apnea will be recruited as a control group.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-Minute Pegboard and Ring Test (6PBRT) Score
Time frame: Baseline
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.
6 secondary outcomes
Test-Retest Reliability of the 6PBRT
Time frame: Within 7 days
Hand Grip Strength
Time frame: Baseline
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Baseline
Epworth Sleepiness Scale (ESS)
Time frame: Baseline
Polysomnography Parameters
Time frame: Baseline
Fatigue Severity Scale (FSS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 25820157Ben 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.
- Results publication: PubMed 19371179Szentkiralyi 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.
- Results publication: PubMed 40361906Iannella 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. The Global Burden of Obstructive Sleep Apnea. Diagnostics (Basel). 2025 Apr 25;15(9):1088. doi: 10.3390/diagnostics15091088.
- Results publication: PubMed 40452394Kang YJ, Park CS. Mechanisms and Management of Obstructive Sleep Apnea: A Translational Overview. Clin Exp Otorhinolaryngol. 2025 Nov;18(4):296-305. doi: 10.21053/ceo.2025-00071. Epub 2025 Jun 2.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be publicly shared to protect participant confidentiality. Only aggregated and anonymized results will be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Sleep Apnea, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact engin ramazanoğlu, Assistant Professor (+905334889447, enginramazanoglu@artuklu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Pegboard and Ring Test (6PBRT) Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465874, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.