NCT03903666

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

March 23, 2019

Last Update Submit

March 1, 2023

Conditions

Down Syndrome

Keywords

Sleep ApnoaDown SyndromeChildrenOSA

Outcome Measures

Primary Outcomes (1)

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

    2 months

Secondary Outcomes (5)

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

    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 assed by the Dysautonomia questionnaire

    2 months

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

    2 months

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

    2 months

Study Arms (1)

Cohort

EXPERIMENTAL

47 Down syndrome patients age from 4 to 16

Other: Nocturnal gaz exchanges measurement

Interventions

Nocturnal gaz exchanges measurementOTHER

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

Cohort

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • OAS diagnostic focused on an earlier polysomnography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Armand Trousseau

Paris, 75012, France

Location

Related Publications (3)

  • 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.

    PMID: 23121137BACKGROUND

  • 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.

    PMID: 25928806BACKGROUND

  • 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.

    PMID: 16924359BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • TAYTARD MD Jessica

    Hôpital Armand Trousseau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Down syndrome patients aged from 4 to 16 years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2019

First Posted

April 4, 2019

Study Start

October 14, 2019

Primary Completion

March 25, 2022

Study Completion

May 23, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)