Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07334444

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.

Recruiting

Interested in participating?

Request Info

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

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

  1. 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

Interested in participating?

Recruiting

Interested in participating?

Request Info

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.