Optimizing the Management of 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.

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Key information

Conditions

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

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Clémence HOUBÉ, MD

SUB_INVESTIGATOR

Guillaume TRAU, MD

CONTACT

[email protected]

Guillaume TRAU, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Apnea-hypopnea index (AHI) before and after surgery.

Time frame: Day 1 before surgery and Day 1 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume TRAU, MD

CONTACT

[email protected]

33 3 88 12 76 44

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SAOS-21

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2026
Registry last updated: Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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