Down Syndrome Obstructive Sleep Apnea

Recruiting Phase 2 Interventional Study
Down Syndrome Obstructive Sleep Apnea
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Brigham and Women's Hospital · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ages 5.0 to 17.9 years at the time of screening 2. Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour. 3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60% as these levels would otherw…
Contacts

Oltion Sina

8573407909

osina@bwh.harvard.edu

CONTACT

Suzie Hicks

5136364944

suzanna.hicks@cchmc.org

CONTACT