Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

Institut Jerome Lejeune

Status: Completed

Conditions: Down Syndrome; Obstructive Sleep Apnea Syndrome

Treatments: Device: Continuous Positive Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT00394290

Morphee

IJL-PPC-EP02

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

PPC

Experimental group

Description:

Night time device for positive pulmonary pressure

Treatment:

Device: Continuous Positive Pressure