Taking people in United StatesPhase 2

Oxygen during sleep for children with Down syndrome and sleep apnea

Tests extra oxygen during sleep in children with Down syndrome and obstructive sleep apnea.

Key facts

Who runs it: Brigham and Women's Hospital
Where: Ann Arbor, Cincinnati, Cleveland, Los Angeles, Norfolk, Philadelphia, and Seattle, United StatesSee the 7 sites
Trial code: NCT06043440
Registry title: Down Syndrome Obstructive Sleep Apnea
Status: Recruiting
Phase: Phase 2
People taking part: 230 people, planned
Started: 24 Oct 2023
Expected to end: 30 Dec 2027
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Oxygen
Record updated: 30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with Down syndrome and moderate to severe obstructive sleep apnea, meaning breathing stops or gets shallow during sleep. It tests whether oxygen during sleep helps memory and other outcomes.

Age: 5.0 to 17.9 years at screening
Sex: All sexes
Disease stage: Obstructive sleep apnea with an obstructive apnea hypopnea index (OAHI) of ≥5/hour. No serious low oxygen levels, meaning oxygen saturation <88% for 5 minutes or drops to 60%.
Earlier treatment: Children who use CPAP well now (> 4 hrs/night; > 70% of nights) cannot join. Children who use extra oxygen long-term during the day or night cannot join.
Biomarker or test result: During a sleep study, oxygen must work well: lowest oxygen saturation >92%, obstructive index falls below 5/hour or by > 50%, CO2 stays under 65 mmHg, and oxygen flow is no more than 3.0 LPM and FiO2 no more than 40 %.

Main reasons for not taking part

Oxygen saturation < 90% at rest while awake
Heart defect present from birth that has not been repaired
Moderate to severe high blood pressure in the lungs treated with oxygen or medicines that widen lung blood vessels
Someone smokes in the child's bedroom
Large tonsils and adenoids where the child can have surgery to remove them and parents agree to it

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

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?

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

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

Oxygen plus supportive care (OXT)Existing treatment, for comparison
Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Treatment: Oxygen
Supportive care (SC)No study treatment, for comparison
Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.