Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Down Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903666
• Other study ID #: TriRespi
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: May 23, 2022

Study information

• Verified date: March 2023
• Source: Institut Jerome Lejeune
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 23, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Armand Trousseau	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Jerome Lejeune	Hôpital Armand Trousseau

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings		2 months
Secondary	Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %		2 months
Secondary	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
Secondary	Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire		2 months
Secondary	Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment		2 months
Secondary	Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire		2 months