Down Syndrome and Continuous Positive Pressure Therapy

Not Applicable

Completed

• Conditions: Down Syndrome; Obstructive Sleep Apnea Syndrome
• Interventions: Device: Continuous Positive Pressure

• Registration Number: NCT00394290
• Lead Sponsor: Institut Jerome Lejeune

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-01
• Study Start: 2006-11-16
• Status Verified: 2012-10
• Primary Completion: 2012-10-31
• Study Completion: 2012-12-31
• Last Update Submitted: 2019-03-23
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPC	Continuous Positive Pressure	Night time device for positive pulmonary pressure

Primary Outcome Measures

Name	Time	Method
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)	0 and 3 months

Secondary Outcome Measures

Name	Time	Method
Tolerability	0, 3 and 12 months

Trial Locations

Locations (1)

Institut Jerome Lejeune; 🇫🇷 Paris, France