Oxygen therapy for children with Down Syndrome and sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of oxygen supplementation during sleep on cognitive function and other health outcomes in children with Down Syndrome who have moderate to severe Obstructive Sleep Apnea. It is a randomized, single-blind study lasting six months, where participants will undergo various assessments including polysomnography, neurocognitive testing, and echocardiography. The study will recruit children from sleep clinics, Down syndrome clinics, and local associations, focusing on those who have not responded to standard treatments like adenotonsillectomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• University of Michigan, Ann Arbor Hospital
  Ann Arbor, Michigan, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Rainbow Babies and Children's Hospital, Case Medical Center
  Cleveland, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• East Virginia Medical Center
  Norfolk, Virginia, United States Recruiting

Study contacts

• Principal investigator: Susan Redline — Brigham and Women's Hospital
• Study coordinator: Oltion Sina
• Email: osina@bwh.harvard.edu
• Phone: 8573407909

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

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• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

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• Functional capacity and muscle function in adults with obstructive sleep apnea

  This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.