NCT06828835

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress14%
Feb 2026Aug 2028

First Submitted

Initial submission to the registry

February 5, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
12 months until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

February 5, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

PediatricsSleep Disorders

Outcome Measures

Primary Outcomes (1)

  • Completion of specialist evaluation

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

    up to 12months

Secondary Outcomes (10)

  • Time from referral to specialist consultation

    12months

  • Completion of PSG

    12months

  • Time to PSG

    12months

  • Receipt of treatment

    12months

  • Time to treatment

    12months

  • +5 more secondary outcomes

Other Outcomes (12)

  • Sociodemographic factors

    Baseline (T0)

  • Clinical characteristics

    Baseline (T0), 12months

  • Social Support

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

  • +9 more other outcomes

Study Arms (2)

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.

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

Usual Care

OTHER

The ordinary course of care.

Other: Usual Care

Interventions

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.

Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)

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

Usual Care

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Phayvanh Pecha, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phayvanh P Pecha, MD

CONTACT

Caroline B King, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 14, 2025

Study Start

February 3, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations