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.
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.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29412
Caroline B King, BS, 8433005600, kingba@musc.edu
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.
- Conditions
- Sleep Apnea, Obstructive
- 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 group | Role | What they receive |
|---|---|---|
| Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE) | Other | REPOSE 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 Care | Other | The 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.
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)
Time from referral to specialist consultation
Time in days from referral order to specialist evaluation (sleep medicine or otolaryngology).
Measured: 12months
Completion of PSG
Binary, PSG (if ordered) was completed within 90 days of the order.
Measured: 12months
Time to PSG
Time in days from PSG order to completion.
Measured: 12months
Receipt of treatment
Binary, treatment completion within 60 days.
Measured: 12months
Time to treatment
Time in days from initial consultation or from PSG results to recommended treatment.
Measured: 12months
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)
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)
Barrier reduction
Proportion and types of barriers resolved.
Measured: 1-2 weeks following enrollment (T1), 12months
Unresolved barriers
Proportion of barriers unresolved by the navigator.
Measured: 12months
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.
- First posted14 Feb 2025
- Study start3 Feb 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Phayvanh Pecha, Medical University of South Carolina
- Investigators
- Phayvanh Pecha, MD, Principal investigator, Medical University of South Carolina
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention
- ClinicalTrials.gov ID
- NCT06828835
- Acronym / sponsor ID
- Pro00138323
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Pediatrics, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Feb 2025 (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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE) | Other | Other: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)REPOSE is a theory-based patient navigation intervention to address multilevel barriers to timely diagnosis and treatment of obstructive sleep-disordered breathing. |
| Usual Care | Other | Other: Usual CareThe ordinary course of care. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients already established with sleep medicine or otolaryngology which would bias ease of completing specialty evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)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. | Other | Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE) |
| Usual CareUsual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care). | Other | Usual Care |
Primary outcome
Completion of specialist evaluation
Time frame: up to 12months
Binary, evaluation of SDB by completion of specialist consultation (e.g., sleep medicine, otolaryngologist) per AAP guidelines.
10 secondary outcomes
Time from referral to specialist consultation
Time frame: 12months
Completion of PSG
Time frame: 12months
Time to PSG
Time frame: 12months
Receipt of treatment
Time frame: 12months
Time to treatment
Time frame: 12months
SDB symptom severity
Time frame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)
Quality of life impact for obstructive sleep apnea in children
Time frame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)
Barrier reduction
Time frame: 1-2 weeks following enrollment (T1), 12months
Unresolved barriers
Time frame: 12months
Self-efficacy
Time frame: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
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 5 Feb 2026.
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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.
Phayvanh Pecha, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
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.