Optimizing the Management of OSA in Children With Down Syndrome (SAOS-21)

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

The objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a management algorithm in France.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Guillaume TRAU, MD; Phone Number: 33 3 88 12 76 44; Email: guillaume.trau@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
    • Principal Investigator: Guillaume TRAU, MD
    • Contact: Guillaume TRAU, MD; Phone Number: 44; Email: guillaume.trau@chru-strasbourg.fr
    • Sub-Investigator: Clémence HOUBÉ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

- Child with Down syndrome, aged between 0 and 17 years and 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index (AHI) before and after surgery.	The AHI is a number that indicates how many times per hour breathing is abnormal during sleep. It adds up: Apneas → breathing stops completely; Hypopneas → breathing becomes much shallower Scores: AHI < 5 → normal; AHI between 5 and 15 → mild impairment; AHI between 15 and 30 → moderate impairment	Day 1 before surgery and Day 1 after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 19, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Down syndrome; Obstructive Sleep Apnea of Child
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Respiratory Tract Diseases; Neurobehavioral Manifestations; Respiration Disorders; Sleep Wake Disorders; Congenital Abnormalities; Abnormalities, Multiple; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Intellectual Disability; Sleep Apnea Syndromes; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea, Obstructive; Down Syndrome
• Other Study ID Numbers: 9617

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No