Down Syndrome Obstructive Sleep Apnea
Key facts
- Where
- Ann Arbor, Cincinnati, Cleveland, Los Angeles, Norfolk, Philadelphia, and Seattle, United StatesSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 18 years old?
Source: NCT06043440, who can take part
Where in United States
- University of Michigan, Ann Arbor HospitalAnn Arbor, United StatesContact: Emily HerreshoffTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Suzanna HicksTaking people
- Rainbow Babies and Children's Hospital, Case Medical CenterCleveland, United StatesContact: Alyssa KellerTaking people
- Children's Hospital of Los AngelesLos Angeles, United StatesContact: Danny Del Cid-LinareTaking people
- East Virginia Medical CenterNorfolk, United StatesContact: Thomas BoswickTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Ebereh UwahTaking people
- Seattle Children's HospitalSeattle, United StatesContact: Sharon McNamaraTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT06043440
- Record updated
- 30 September 2026
- Original description
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).Read full original descriptionShow less
Randomized Control Trial of Oxygen Therapy in Children and Adolescents With Down Syndrome and Obstructive Sleep Apnea
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).
Inclusion: 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: Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator; Individuals who develop alveolar hypoventilation with oxygen as previously defined; Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery; Unrepaired congenital heart disease; Other severe chronic diseases determined by their provider as making them poor study candidates; 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; Unable to participate in a PSG; 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.