Early Detection and Treatment of Obstructive Sleep Apnoea in Infants With Down Syndrome

Interventional, comparative, open-label, single-center study to demonstrate that early (from 6 months of age) and systematic (every 6 months) screening for Obstructive Sleep Apnoea (OSA) by polysomnography (PSG) in infants with Down syndrome during the first 3 years of life is associated with improved neurodevelopment at 3 years of age, with sustained benefits up to 5 years of age.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstructive Sleep Apnea of Newborn

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jérome Lejeune

Paris, Sélectionnez l'État/Province, 75015, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Down Syndrome Age 6 months or less for the Study Group Age 30 to 36 months for the Standard Care Group Living in Paris or Paris area (75, 77, 78, 92, 93, 94, 95) Parents or legal representative agreeing with the study requirements and able to understand, date and sign the informed consent form before study enrollment French language is native mother tongue

Exclusion criteria

Gestationnel age < 36 completed amenorrhoea weeks Patient who have or had acute CNS suffering signs Patients with Down Syndrome already had continuous positive airway pressure treatment for OSA Patients participating in another clinical study or for whom a participation to another biomedical research is expected before the end or their follow-up

Treatment and study plan

Polysomnography (PSG)

Diagnostic Test

PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years

Primary outcomes

Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores

Time frame: At the age of 3 years

Median Griffiths III scores at the age of 3 years will be compared between the 2 groups

Sponsors and collaborators

Lead sponsor

Institut Jerome Lejeune

Other

Collaborators

Hôpital Necker-Enfants Malades

Registry information

Acronym: RESPIRE21

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2024
First posted: Jul 7, 2017
Registry last updated: Sep 21, 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.

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

Completed