Down Syndrome Obstructive Sleep Apnea

Summary

The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).

Conditions

• Down Syndrome
• Obstructive Sleep Apnea

Interventions

DRUG

Oxygen

Active nocturnal oxygen concentrator

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Rainbow Babies and Children's Hospital

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital of The King's Daughters

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Susan Redline · Brigham and Women's Hospital

• Raouf Amin · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-24

Primary Completion

2027-11-30

Completion

2027-12-30

FDA Drug

Yes

Countries

• United States

Study Locations