Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Sponsor
Institut Jerome Lejeune (Other)
Overall Status
Recruiting
CT.gov ID
NCT03903666
Collaborator
Hôpital Armand Trousseau (Other)
47
1
1
26.6
1.8

Study Details

Study Description

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. .

Condition or Disease Intervention/Treatment Phase
  • Other: Nocturnal gaz exchanges measurement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Down syndrome patients aged from 4 to 16 yearsDown syndrome patients aged from 4 to 16 years
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years
Actual Study Start Date :
Oct 14, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort

47 Down syndrome patients age from 4 to 16

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings [2 months]

Secondary Outcome Measures

  1. Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in % [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. [2 months]

  3. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire [2 months]

  4. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment [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 [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Armand Trousseau Paris France 75012

Sponsors and Collaborators

  • Institut Jerome Lejeune
  • Hôpital Armand Trousseau

Investigators

  • Principal Investigator: TAYTARD MD Jessica, Hôpital Armand Trousseau

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institut Jerome Lejeune
ClinicalTrials.gov Identifier:
NCT03903666
Other Study ID Numbers:
  • TriRespi
First Posted:
Apr 4, 2019
Last Update Posted:
Aug 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Jerome Lejeune
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2021