Comparing oxygen delivery methods for children with obstructive 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 study conducts a randomized control trial to compare two methods of oxygen delivery—continuous flow and pulse flow—in children with Down syndrome suffering from moderate to severe obstructive sleep apnea. The trial involves 15 participants from Cincinnati Children's Hospital and Children's Hospital of Los Angeles, where each child will undergo two polysomnographies to assess the effectiveness of each method. The goal is to gather data that could inform a larger project aimed at evaluating the impact of oxygen treatment on obstructive apnea frequency and related neurocognitive and cardiac outcomes. This pilot study is crucial for understanding the potential benefits of pulse flow oxygen concentrators in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 5-17 years with or without Down Syndrome (DS).
2. Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
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.

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. Unable to participate in a Polysomnogram (PSG).
5. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Raouf Amin, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Suzie Hicks, BS
• Email: suzie.hicks@cchmc.org
• Phone: 513-636-4944

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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.