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NCT00394290 Clinical Trial

Down Syndrome and Continuous Positive Pressure Therapy

Down Syndrome Clinical Trial

— Morphee  

Official title:
Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394290
Other study ID # IJL-PPC-EP02
Secondary ID Morphee
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2006
Est. completion date December 31, 2012

Study information
Verified date October 2012
Source Institut Jerome Lejeune
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date December 31, 2012
Est. primary completion date October 31, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Down Syndrome patients with an Obstructive Sleep Apnea Syndrome

- more than 18 years old

Exclusion Criteria:

- predictable non-compliance of device

- non-compensated cardiopathy

- non-stable thyroxin treatment

- non-stable diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous Positive Pressure
Nighttime continuous positive pressure device, to be used every day

Locations
Country Name City State
France Institut Jerome Lejeune Paris

Sponsors (2)
Lead Sponsor Collaborator
Institut Jerome Lejeune Fondation Jérôme Lejeune

Country where clinical trial is conducted

France, 

References & Publications (1)

Resta O, Barbaro MP, Giliberti T, Caratozzolo G, Cagnazzo MG, Scarpelli F, Nocerino MC. Sleep related breathing disorders in adults with Down syndrome. Downs Syndr Res Pract. 2003 Aug;8(3):115-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) 0 and 3 months
Secondary Tolerability 0, 3 and 12 months
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