StudyFinder
Down Syndrome Obstructive Sleep Apnea
RECRUITING
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).
ALL
5 years to 18 years old
Inclusion Criteria:
- Ages 5.0 to 17.9 years at the time of screening
- Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.
- 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.
Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
- Oxygen saturation nadir >92% and
- Decrease in obstructive index < 5 / hour or by > 50% from screening PSG
- 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.
- Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 > 40 %.
Willingness to comply with all study procedures and available for duration of study.
At baseline the participant attempts to perform the neuropsychological tests
Exclusion Criteria:
- Current CPAP use with documented compliance(> 4 hrs/ night; > 70% of nights).
- Oxygen saturation < 90% at rest during wakefulness.
- Chronic daytime or nighttime use of supplemental oxygen.
- Smoker in the child's bedroom.
- Unrepaired congenital heart disease.
- Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
- Unable to participate in a PSG.
- Individuals who develop alveolar hypoventilation with oxygen as previously defined.
- Other severe chronic diseases determined by their provider as making them poor study candidates.
- Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
- Documented clinically significant untreated hypothyroidism
- Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
DRUG: Oxygen
Down Syndrome, Obstructive Sleep Apnea