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Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03903666
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Hôpital Armand Trousseau
Information provided by (Responsible Party):
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. .

Condition or disease Intervention/treatment Phase
Down Syndrome Other: Nocturnal gaz exchanges measurement Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Down 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
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

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




Primary Outcome Measures :
  1. Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings [ Time Frame: 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 % [ Time Frame: 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. [ Time Frame: 2 months ]
  3. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire [ Time Frame: 2 months ]
  4. Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment [ Time Frame: 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 [ Time Frame: 2 months ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903666


Contacts
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Contact: TAYTARD MD Jessica +33 1 71 73 84 11 jessica.taytard@aphp.fr
Contact: WALTI MD Herve + 33 1 56 58 63 00 herve.walti@institutlejeune.org

Locations
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France
Hôpital Armand Trousseau Not yet recruiting
Paris, France, 75012
Contact: TAYTARD MD Jessica    + 33 1 71 73 87 11    jessica.taytard@aphp.fr   
Contact: RICHARD MD Nicolas    + 33 1 71 73 87 11    nicolas.richard@aphp.fr   
Sub-Investigator: AUBERTIN MD Guillaume         
Sponsors and Collaborators
Institut Jerome Lejeune
Hôpital Armand Trousseau
Investigators
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Principal Investigator: TAYTARD MD Jessica Hôpital Armand Trousseau

Publications:
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Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT03903666     History of Changes
Other Study ID Numbers: TriRespi
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Jerome Lejeune:
Sleep Apnoa
Down Syndrome
Children
OSA

Additional relevant MeSH terms:
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Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn