Optimizing the Management of OSA in Children With Down Syndrome

NCT07334444 | Recruiting

• 1 other identifier: 9617
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea of Child; Down syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Down Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Central Study Contacts

Guillaume TRAU, MD

CONTACT

33 3 88 12 76 44; guillaume.trau@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: March 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

FR (1)