Down Syndrome Obstructive Sleep Apnea

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether giving extra oxygen during sleep can help improve memory and other important health outcomes for children and teenagers with Down Syndrome who also have a condition called Obstructive Sleep Apnea (OSA). OSA causes breathing problems during sleep, which can affect a child's rest and overall well-being. The study is looking for participants aged 5 to 17 years who experience moderate to severe OSA but do not have serious breathing issues when awake.

If your child is eligible and decides to join the study, they will receive oxygen therapy while sleeping and will be monitored to see how it affects their memory and other health indicators. Participants will undergo tests to ensure they respond well to the oxygen and can tolerate it safely. It's important to note that children who currently use a CPAP machine (a device that helps with OSA) or have certain health issues may not be able to participate. This study aims to better understand the benefits of oxygen therapy for improving sleep quality and cognitive function in these young patients.

Gender

ALL

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.