Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Not Applicable

Completed

• Conditions: Down Syndrome

• Registration Number: NCT03903666
• Lead Sponsor: Institut Jerome Lejeune

Brief Summary

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. .

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-03-23
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2019-10-14
• Primary Completion: 2022-03-25
• Study Completion: 2022-05-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings	2 months

Secondary Outcome Measures

Name	Time	Method
Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire	2 months
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.	2 months
Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment	2 months
Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %	2 months
Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire	2 months

Trial Locations

Locations (1)

Hôpital Armand Trousseau; 🇫🇷 Paris, France