Actively Recruiting
Down Syndrome Obstructive Sleep Apnea
Led by Brigham and Women's Hospital · Updated on 2025-04-20
230
Participants Needed
7
Research Sites
218 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
C
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Down Syndrome Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 5.0 to 17.9 years at the time of screening
- Diagnosed with obstructive sleep apnea with an obstructive apnea hypopnea index (OAHI) of 5 or more per hour
- No clinically significant hypoxia (oxygen saturation below 88% for 5 minutes or episodes below 60%)
- Positive response to oxygen therapy during sleep, defined by improved oxygen saturation nadir (>92%) and reduced obstructive index
- Oxygen flow required does not exceed 3.0 LPM and fraction of inspired oxygen (FiO2) does not exceed 40%
- Willing to comply with all study procedures and available for the full study duration
- Able to attempt neuropsychological testing at baseline
You will not qualify if you...
- Currently using CPAP with compliance over 4 hours per night on more than 70% of nights
- Oxygen saturation below 90% while awake at rest
- Chronic use of supplemental oxygen during the day or night
- Smoker in the child's bedroom
- Unrepaired congenital heart disease
- Moderate to severe pulmonary hypertension requiring oxygen or pulmonary vasodilator treatment
- Unable to participate in a polysomnography (PSG)
- Development of alveolar hypoventilation with oxygen therapy
- Other severe chronic diseases deemed unsuitable by provider
- Enrolled or planning to enroll in conflicting clinical studies
- Untreated clinically significant hypothyroidism
- Adenotonsillar hypertrophy with parents agreeing to adenotonsillectomy surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of Michigan, Ann Arbor Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Rainbow Babies and Children's Hospital, Case Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
East Virginia Medical Center
Norfolk, Virginia, United States, 23507
Actively Recruiting
7
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
O
Oltion Sina
CONTACT
S
Suzie Hicks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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