Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

NCT ID: NCT03903666

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2022-05-23

Brief Summary

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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

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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

Conditions

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Down Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Down syndrome patients aged from 4 to 16 years
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort

47 Down syndrome patients age from 4 to 16

Group Type EXPERIMENTAL

Nocturnal gaz exchanges measurement

Intervention Type OTHER

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

Interventions

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Nocturnal gaz exchanges measurement

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Armand Trousseau

OTHER

Sponsor Role collaborator

Institut Jerome Lejeune

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TAYTARD MD Jessica

Role: PRINCIPAL_INVESTIGATOR

Hôpital Armand Trousseau

Locations

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Hôpital Armand Trousseau

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16924359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23121137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25928806 (View on PubMed)

Other Identifiers

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TriRespi

Identifier Type: -

Identifier Source: org_study_id

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