RecruitingDown SyndromeObstructive Sleep Apnea
Down Syndrome Obstructive Sleep Apnea
Eligible age
5–18 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ 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 otherwise identify children eligible to routinely receive oxygen.
- ✓ 4. Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
- ✓ 1. Oxygen saturation nadir \>92% and
- ✓ 2. Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG
- ✓ 3. Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
- ✓ 4. Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.
You may not qualify if…
- ✕ 1. Current CPAP use with documented compliance(\> 4 hrs/ night; \> 70% of nights).
- ✕ 2. Oxygen saturation \< 90% at rest during wakefulness.
- ✕ 3. Chronic daytime or nighttime use of supplemental oxygen.
- ✕ 4. Smoker in the child's bedroom.
- ✕ 5. Unrepaired congenital heart disease.
- ✕ 6. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
- ✕ 7. Unable to participate in a PSG.
- ✕ 8. Individuals who develop alveolar hypoventilation with oxygen as previously defined.
Where it's recruiting
California
Los Angeles
Michigan
Ann Arbor
Ohio
Cincinnati · Cleveland
Pennsylvania
Philadelphia
Virginia
Norfolk
Washington
Seattle
Source: ClinicalTrials.gov · NCT06043440 · last updated 2025-04-20