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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03210675

Acronym

RESPIRE21

Enrollment

Registered

2017-07-07

Start date

2017-07-31

Completion date

2024-02-29

Last updated

2026-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Obstructive Sleep Apnea of Newborn

Brief summary

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.

Interventions

DIAGNOSTIC_TESTPolysomnography (PSG)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Interventional, comparative, open label, multi-center study

Eligibility

Sex/Gender

ALL

Age

6 Months to 3 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Median Griffiths Scales of Child Development, Third Edition (Griffiths III) Scores	At the age of 3 years	Median Griffiths III scores at the age of 3 years will be compared between the 2 groups

Countries

France

Contacts

STUDY_CHAIRBrigitte FAUROUX, Professor

Hôpital Necker-Enfants Malade

PRINCIPAL_INVESTIGATORClotilde MIRCHER, Doctor

Institut Jérôme Lejeune

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 22, 2026