Improving care for obstructive sleep apnea in children with Down syndrome

Current Status Assessment for the Development of a Protocol to Optimize the Management of Obstructive Sleep Apnea (OSA) in Children With Down Syndrome

This project reviews past medical records to see how children with Down syndrome were screened and surgically treated for obstructive sleep apnea at Strasbourg University Hospital and will produce a management algorithm for use in France.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 0 Years to 17 Years
• Sex: All
• Sponsor: University Hospital, Strasbourg, France (other)
• Locations: 1 site (Strasbourg)
• Trial ID: NCT07334444 on ClinicalTrials.gov

What this trial studies

This is a retrospective descriptive review of ENT and sleep clinic records for children with Down syndrome seen at the University Hospital of Strasbourg between January 1, 2019 and December 31, 2024. The team will document current screening practices, diagnostic pathways, and surgical treatment patterns for obstructive sleep apnea in this population. Records with a written objection to data reuse will be excluded and no new procedures will be performed on patients. The final output will be a proposed management algorithm intended for dissemination to clinicians in France.

Who should consider this trial

Good fit: Children with Down syndrome aged 0–17 who had an ENT consultation or a visit to the Sleep Center at the University Hospital of Strasbourg between January 1, 2019 and December 31, 2024 and whose records do not contain a written objection to data reuse.

Not a fit: Children outside the 0–17 age range, those not seen at the Strasbourg ENT/Sleep Center during the study period, or whose medical files include a written objection to data reuse will not be included and are unlikely to receive direct benefit from this record review.

Why it matters

Potential benefit: If successful, this work could help standardize screening and surgical management across France, leading to earlier diagnosis and improved sleep and breathing outcomes for affected children.

How similar studies have performed: Previous observational studies have documented high OSA prevalence and benefit from tailored surgical management in children with Down syndrome, but few have produced national management algorithms, so this project builds on existing evidence while addressing a gap in standardized guidance.

Eligibility criteria

Inclusion Criteria:

* Child with Down syndrome,
* Aged between 0 and 17 years,
* Having been seen for an ENT consultation at the University Hospital or the Sleep Center of the University Hospital of Strasbourg between January 1, 2019, and December 31, 2024

Exclusion Criteria:

\- Presence of a written objection in the medical file of the subject (and/or their representative) to the reuse of their data for scientific research purposes.

Where this trial is running

Strasbourg

• Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)

Study contacts

• Study coordinator: Guillaume TRAU, MD

Conditions: Obstructive Sleep Apnea, Obstructive Sleep Apnea of Child, Down syndrome