Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea

2023P000062

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).

2023-10-24

2027-08-31

2027-12-27

Recruiting

Early phase I

230

Inclusion Criteria: 1. Ages 5.0 to 17.9 years at the time of screening 2. Children with Obstructive Sleep Apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40/hour. : 3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60%. 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 without hypoventilation. 4. Oxygen flow required does not exceed 3.0 liter/minute or Fraction of Inspired Oxygen (FiO2) \>40%. 5. Willingness to comply with all study procedures and be available for the 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.

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2024-02-22