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Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nocturnal gaz exchanges measurement
Sponsored by
Institut Jerome Lejeune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Down Syndrome focused on measuring Sleep Apnoa, Down Syndrome, Children, OSA

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Armand Trousseau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort

Arm Description

47 Down syndrome patients age from 4 to 16

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2019
Last Updated
March 1, 2023
Sponsor
Institut Jerome Lejeune
Collaborators
Hôpital Armand Trousseau
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1. Study Identification

Unique Protocol Identification Number
NCT03903666
Brief Title
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome
Official Title
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Jerome Lejeune
Collaborators
Hôpital Armand Trousseau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Sleep Apnoa, Down Syndrome, Children, OSA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Down syndrome patients aged from 4 to 16 years
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Experimental
Arm Description
47 Down syndrome patients age from 4 to 16
Intervention Type
Other
Intervention Name(s)
Nocturnal gaz exchanges measurement
Intervention Description
Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment
Primary Outcome Measure Information:
Title
Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %
Time Frame
2 months
Title
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
Title
Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire
Time Frame
2 months
Title
Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment
Time Frame
2 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAYTARD MD Jessica
Organizational Affiliation
Hôpital Armand Trousseau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23121137
Citation
Feldman JL, Del Negro CA, Gray PA. Understanding the rhythm of breathing: so near, yet so far. Annu Rev Physiol. 2013;75:423-52. doi: 10.1146/annurev-physiol-040510-130049. Epub 2012 Oct 29.
Results Reference
background
PubMed Identifier
25928806
Citation
Trang H, Brunet JF, Rohrer H, Gallego J, Amiel J, Bachetti T, Fischbeck KH, Similowski T, Straus C, Ceccherini I, Weese-Mayer DE, Frerick M, Bieganowska K, Middleton L, Morandi F, Ottonello G; European Central Hypoventilation Syndrome Consortium. Proceedings of the fourth international conference on central hypoventilation. Orphanet J Rare Dis. 2014 Dec 5;9:194. doi: 10.1186/s13023-014-0194-5.
Results Reference
background
PubMed Identifier
16924359
Citation
Ng DK, Hui HN, Chan CH, Kwok KL, Chow PY, Cheung JM, Leung SY. Obstructive sleep apnoea in children with Down syndrome. Singapore Med J. 2006 Sep;47(9):774-9.
Results Reference
background

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Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

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