Early Detection and Treatment of Respiratory Sleep Disorders in Children With Down Syndrome (RESPIRE21)

Institut Jerome Lejeune

Status: Active, not recruiting

Conditions: Down Syndrome; Obstructive Sleep Apnea of Newborn

Treatments: Diagnostic Test: Polysomnography (PSG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03210675

DP-TRS-T21

Details and patient eligibility

About

Interventional, comparative, open label, single-center study to demonstrate that an early (from 6 months of age) and systematic (every 6 months) screening of Obstructive Sleep Apnea (OSA) by polysomnography (PSG) in children with Down Syndrome during the first 3 years of life is associated with an improved neurocognitive development at the age of 3 years.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Study group

Other group

Description:

Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.

Treatment:

Diagnostic Test: Polysomnography (PSG)

Standard Care Group

Other group

Description:

Will have a single PSG at home which will give a reference in the Down Syndrome population of 3 years old and will be used as reference to the study group

Treatment:

Diagnostic Test: Polysomnography (PSG)