# Positive Airway Pressure For The Treatment Of The Obstructive Sleep Apnea Syndrome In Children With Down Syndrome

> **NIH NIH R33** · CHILDREN'S HOSP OF PHILADELPHIA · 2021 · $976,385

## Abstract

Abstract
Individuals with Down syndrome (DS) are predisposed to OSAS due to craniofacial features (midface
hypoplasia, glossoptosis) and studies have shown that the prevalence of OSAS in this population is markedly
increased compared to that of typically developing children. Adenotonsillectomy (AT) is considered first-line
treatment for childhood OSAS. However, OSAS resolves in only a portion of children with DS after AT. In fact,
many children with DS are referred for positive airway pressure (PAP) therapy initiation due to persistent
OSAS after AT, and PAP appears to be an important feature of the experience of living with DS. PAP has been
shown to be highly effective at treating OSAS and improve OSAS-associated neurobehavioral symptoms, such
as quality of life, behavior, mood, daytime sleepiness and school performance. However, PAP as a treatment
for OSAS has not been well-studied in children with DS. Furthermore, patient/family reported outcomes are an
important knowledge gap long overdue in this population. Therefore, we propose to leverage the HEalthy
SLeeP for Children with Down Syndrome (HELP-DS, U01HL125295-S1 and U01HL123507-S1) infrastructure
and conduct in two HELP-DS sites (Philadelphia and Cincinnati) a mixed methods study during the R61 phase
of the award that will inform the randomized controlled trial proposed during the R33 part of the award.
Families of children with DS and OSAS who are already being treated with PAP will be interviewed to identify
family-relevant outcomes as these may differ from healthcare providers-relevant outcomes, and inform
healthcare providers about family-relevant determinants of PAP adherence. During the R33 phase of the
award, we aim at recruiting 86 children with DS and OSAS at 2 sites, aged 6-18 years, referred to PAP
initiation for the treatment of OSAS. Participants will be randomized to a 6-month intensive behavioral
intervention (INT) to improve PAP adherence vs standard clinical care (CON) and undergo standardized
evaluations of quality of life, behavior, attention, family-relevant outcomes identified during the R61 phase,
PAP adherence, and health care utilization at baseline, 6, and 12 months. This rigorous design and
comprehensive study will resolve existing uncertainties on initial management approaches for children with DS
and OSAS treated with PAP by addressing critical issues: a) assess outcomes of importance to families, b)
determine the efficacy of INT vs CON in promoting PAP adherence, c) elucidate which factors mediate or
moderate adherence to PAP in children with DS and OSAS, d) determine the effect of PAP use on
neurobehavioral and family-relevant outcomes, quality of life, and healthcare utilization.

## Key facts

- **NIH application ID:** 10274785
- **Project number:** 4R33HL151253-03
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Ignacio Esteban Tapia
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $976,385
- **Award type:** 4N
- **Project period:** 2019-09-23 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10274785

## Citation

> US National Institutes of Health, RePORTER application 10274785, Positive Airway Pressure For The Treatment Of The Obstructive Sleep Apnea Syndrome In Children With Down Syndrome (4R33HL151253-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10274785. Licensed CC0.

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