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Sleep Apnea, ObstructiveNCT06828835

The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention

A study testing Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE) in people with Sleep Apnea, Obstructive, run by Medical University of South Carolina at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research study aims to find out the effect of REPOSE, a patient navigation intervention, on the receipt of equitable care among children with a broad range of socioeconomic and rural/urban status with Sleep Disordered Breathing (SDB). Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
3 Feb 2026to 31 Aug 2028
Phase
Interventional
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 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Parents or caregivers (18 and older) of children who were referred by any primary care for SDB evaluation with sleep medicine or pediatric otolaryngology
  • Patients 2.00 to 11.99 years old
  • Parents with a working phone who are willing to participate in the study for a 12-month period after enrollment

Who cannot join

  • Patients already established with sleep medicine or otolaryngology which would bias ease of completing specialty evaluation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Phayvanh P Pecha, MD contact

612-267-8739

pechap@musc.edu

Caroline B King, BS contact

843-300-5600

kingba@musc.edu

United States1 site, 1 recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29412

    Caroline B King, BS, 8433005600, kingba@musc.edu

    Recruiting

Other trials in United States

About this study

Official title: Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention

This research study aims to find out the effect of REPOSE, a patient navigation intervention, on the receipt of equitable care among children with a broad range of socioeconomic and rural/urban status with Sleep Disordered Breathing (SDB).

In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care.

This study will evaluate the effects of the REPOSE intervention on SDB care delivery and clinical process outcomes for children with a broad range of socioeconomic and rural/urban status by reducing barriers and increasing self-efficacy among parents.

Read the detailed description

Sleep disordered breathing (SDB), defined as nocturnal respiratory disturbances ranging from snoring to severe obstructive sleep apnea, affects 12% children in the United States. The American Academy of Pediatrics recommends that all children be screened for snoring, and that those with symptoms or signs of SDB are further evaluated for medical treatment. Despite this recommendation, the rates for recognizing and screening SDB remain low. Black children are also 4-6 times more likely to have SDB but are less likely to undergo evaluation and to receive timely standard of care treatments to address their SDB. Untreated SDB is associated with significant health consequences including behavioral impairments, poor academic performance, and neurocognitive deficits. While evidence-based treatment is available, it is not accessible to all. Black children are 83% less likely than their White peers to attend consultations for SDB. A critical need exists for a theory-based intervention to reduce barriers to care for children with SDB.

Patient navigation is an evidence-based intervention that has been shown to improve screening, referral, and treatment in many health conditions and has high potential to be a culturally acceptable intervention to promote equity in the setting of racial disparities in SDB. Preliminary data informed the development of a novel, multilevel theory-based patient navigation intervention, Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE). In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. In this hybrid type I effectiveness implementation study, the candidate will conduct a pilot randomized controlled trial (RCT) in which N=80 parent-child dyads will be randomized to REPOSE or usual care for SDB. The study team will examine the extent to which the REPOSE intervention improves rates of adherence to evidence-based guidelines among children with a broad range of socioeconomic and rural/urban status with SDB and changes in barrier resolution and self-efficacy among parents. In addition, barriers and facilitators to implementation will be evaluated as guided by the Consolidated Framework for Implementation Research (CFIR) with a focus on social determinants of health.

The findings of this randomized pilot trial will inform the design of a future fully powered RCT.

Being tested
Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE), Usual Care
Keywords
Pediatrics, Sleep Disorders
Medical subject headings
Sleep Apnea, Obstructive, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)Other

    The REPOSE intervention consists of a centralized patient navigator who (1) identifies and addresses dynamic individual barriers, (2) provides support for parent-child dyads, and (3) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. The goals of the REPOSE intervention are to systematically address barriers to care, develop parental self-efficacy to enhance healthcare utilization (e.g., receipt of recommended care and adherence to evidence-based care), and to improve symptom severity and quality of life.

  • Usual CareOther

    Usual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care).

Study groups in NCT06828835
Study groupRoleWhat they receive
Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)OtherREPOSE is a theory-based patient navigation intervention to address multilevel barriers to timely diagnosis and treatment of obstructive sleep-disordered breathing.
Receives: Other: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)
Usual CareOtherThe ordinary course of care.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of specialist evaluation

    Binary, evaluation of SDB by completion of specialist consultation (e.g., sleep medicine, otolaryngologist) per AAP guidelines.

    Measured: up to 12months

Secondary outcomes (10)
  1. Time from referral to specialist consultation

    Time in days from referral order to specialist evaluation (sleep medicine or otolaryngology).

    Measured: 12months

  2. Completion of PSG

    Binary, PSG (if ordered) was completed within 90 days of the order.

    Measured: 12months

  3. Time to PSG

    Time in days from PSG order to completion.

    Measured: 12months

  4. Receipt of treatment

    Binary, treatment completion within 60 days.

    Measured: 12months

  5. Time to treatment

    Time in days from initial consultation or from PSG results to recommended treatment.

    Measured: 12months

  6. SDB symptom severity

    Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder (PSQ-SRBD) Scale is a 22-item scale which measures symptoms of obstructive sleep apnea including snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric obstructive sleep apnea features. The responses are 0 "No" and 1 "Yes". The instrument is scored by averaging the response on non-missing items. A score greater than 0.33 corresponds to a high risk for a pediatric sleep-related breathing disorder.

    Measured: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)

  7. Quality of life impact for obstructive sleep apnea in children

    Sleep-specific quality of life; Obstructive Sleep Apnea (OSA-18) is an 18-item health-related quality of life survey to measure the quality- of-life impact for obstructive sleep apnea syndrome in children.

    Measured: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)

  8. Barrier reduction

    Proportion and types of barriers resolved.

    Measured: 1-2 weeks following enrollment (T1), 12months

  9. Unresolved barriers

    Proportion of barriers unresolved by the navigator.

    Measured: 12months

  10. Self-efficacy

    The NIH Toolbox Self-Efficacy Item Bank is a 10-item survey designed to assess the participant's belief in his or her capacity to manage problems and have control over meaningful events.

    Measured: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start3 Feb 2026
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828835
Sponsor's protocol ID
Pro00138323
Other IDs
1K23HL171952-01A1
Status last verified
Feb 2026
First submitted
5 Feb 2025
Last updated
5 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE) in people with Sleep Apnea, Obstructive, run by Medical University of South Carolina at 1 site in United States.

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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 United States. 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 Phayvanh P Pecha, MD (612-267-8739, pechap@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion of specialist evaluation (time frame: up to 12months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Feb 2026.

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