MedTrace Logo

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

NCT03210675 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

  • Down Syndrome
  • Obstructive Sleep Apnea of Newborn

Interventions

DIAGNOSTIC_TEST

Polysomnography (PSG)

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

Sponsors & Collaborators

  • Hôpital Necker-Enfants Malades

    collaborator OTHER

  • Institut Jerome Lejeune

    lead OTHER

Principal Investigators

  • Brigitte FAUROUX, Professor · Hôpital Necker-Enfants Malade

  • Clotilde MIRCHER, Doctor · Institut Jérôme Lejeune

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2022-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210675 on ClinicalTrials.gov