Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Study Overview
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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

Official Title
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Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years

Conditions
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Down Syndrome

Intervention / Treatment
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* Other: Nocturnal gaz exchanges measurement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Down syndrome patients aged from 4 to 16 years
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort<br>47 Down syndrome patients age from 4 to 16 | Other: Nocturnal gaz exchanges measurement<br>* Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnoa, Down Syndrome, Children, OSA