Skip to main content
OpenTrials
Completed

NCT Number: NCT03903666

Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Recently, retrospective studies have shown that Down Syndrome children have a higher CO2 (carbone dioxide) sleep pressure than the general pediatric population. This increase does not seem to be always related to sleep apnea. The Investigators wish to confirm these results prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with Down syndrome. .

Completed

Looking for future studies?

Notify Me

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

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Armand Trousseau

Paris, 75012, France

About this study

47 Down syndrome patients age from 4 to 16 will be included. They will perform a medical visit at J0, then a measurement of gaz nocturnal exchanges at home within 1 month

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Down syndrome patient without mosaicism
  • Age 4 to 16 years
  • Predominant French language in the living environment

Exclusion criteria

  • OAS diagnostic focused on an earlier polysomnography
  • Methylphenidate treatment started before inclusion

Treatment and study plan

Nocturnal gaz exchanges measurement

Other

Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment

Primary outcomes

  1. Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings

    Time frame: 2 months

Secondary outcomes

  1. Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %

    Time frame: 2 months

  2. Number of patients with low mean, minimum and maximum SpO2 (oyxygen saturation) and/or % of Total sleep time spent with a PtcCO2 higher than 50 mmHg, higher than 20%, as measured by nocturnal gas exchange recordings.

    Time frame: 2 months

  3. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire

    Time frame: 2 months

  4. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment

    Time frame: 2 months

  5. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Institut Jerome Lejeune

Other

Collaborators

  • Hôpital Armand Trousseau

Registry information

Official study title

Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Mar 2, 2023

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.

Related clinical trials

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