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

Not Applicable

Active, not recruiting

• Conditions: Obstructive Sleep Apnea of Newborn; Down Syndrome
• Interventions: Diagnostic Test: Polysomnography (PSG)

• Registration Number: NCT03210675
• Lead Sponsor: Institut Jerome Lejeune

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-07-31
• Primary Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Polysomnography (PSG)	Will have a PSG at home every 6 months (± 1 month) from the age of 6 months until the age of 3 years.
Standard Care Group	Polysomnography (PSG)	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

Primary Outcome Measures

Name	Time	Method
Mean Griffith Mental Development Scale (GMDS) scores	At the age of 3 years	Mean Griffith Mental Development Scale (GMDS) scores at the age of 3 years will be compared between the 2 groups

Trial Locations

Locations (1)

Institut Jérome Lejeune; 🇫🇷 Paris, France