Comparing oxygen delivery methods for children with obstructive sleep apnea

Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep

This study is testing whether two different ways of delivering oxygen can help children with Down syndrome who have moderate to severe obstructive sleep apnea breathe better during sleep.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT06609694 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children aged 5-17 years with Down syndrome or obstructive sleep apnea and an obstructive apnea hypopnea index between 5-40 per hour.

Not a fit: Patients currently using CPAP with documented compliance or those with significant hypoxia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and portable oxygen delivery method for children with obstructive sleep apnea, improving their overall health and quality of life.

How similar studies have performed: While pulse flow oxygen concentrators have been used in adults, this approach is novel in the pediatric population, particularly for those with Down syndrome.

Eligibility criteria

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 this trial is running

Cincinnati, Ohio

• 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

Conditions: Obstructive Apnea, Sleep Apnea, Down Syndrome, Continuous Positive Airway Pressure