NCT07465874

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 6, 2026

Last Update Submit

March 6, 2026

Conditions

Keywords

6-Minute Pegboard and Ring TestUpper Extremity Functional CapacityPolysomnographyObstructive Sleep ApneaFunctional Performance

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (6)

  • Test-Retest Reliability of the 6PBRT

    Within 7 days

  • Hand Grip Strength

    Baseline

  • Functional Outcomes of Sleep Questionnaire (FOSQ)

    Baseline

  • Epworth Sleepiness Scale (ESS)

    Baseline

  • Polysomnography Parameters

    Baseline

  • +1 more secondary outcomes

Study Arms (4)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Artuklu University

Mardin, Mardin, 47510, Turkey (Türkiye)

Location

Related Publications (4)

  • 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

    RESULT
  • Kang YJ,Park CS

    RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

engin ramazanoğlu, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations