NCT06043440 Down Syndrome Obstructive Sleep Apnea
| NCT ID | NCT06043440 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 230 participants in total. It began in 2023-10-24 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 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 %. 5. Willingness to comply with all study procedures and available for duration of study. 6. At baseline the participant attempts to perform the neuropsychological tests Exclusion Criteria: 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. 9. Other severe chronic diseases determined by their provider as making them poor study candidates. 10. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial. 11. Documented clinically significant untreated hypothyroidism 12. Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
Contact & Investigator
Susan Redline
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06043440 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06043440 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06043440 currently recruiting?
Yes, NCT06043440 is actively recruiting participants. Contact the research team at osina@bwh.harvard.edu for enrollment information.
Where is the NCT06043440 trial being conducted?
This trial is being conducted at Los Angeles, United States, Ann Arbor, United States, Cincinnati, United States, Cleveland, United States and 3 additional locations.
Who is sponsoring the NCT06043440 clinical trial?
NCT06043440 is sponsored by Brigham and Women's Hospital. The principal investigator is Susan Redline at Brigham and Women's Hospital. The trial plans to enroll 230 participants.