Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

March 23, 2019 updated by: Institut Jerome Lejeune

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Institut Jérôme Lejeune

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPC
Night time device for positive pulmonary pressure
Device: Continuous Positive Pressure
Nighttime continuous positive pressure device, to be used every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)
Time Frame: 0 and 3 months
0 and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability
Time Frame: 0, 3 and 12 months
0, 3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Jerome Lejeune

Collaborators

Fondation Jérôme Lejeune

Investigators

  • Principal Investigator: Martine Conte, M.D., Institut Jérôme Lejeune
  • Study Director: Franck STURTZ, M.D., Institut Jérôme Lejeune

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2006

Primary Completion (Actual)

October 31, 2012

Study Completion (Actual)

December 31, 2012

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 23, 2019

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IJL-PPC-EP02
  • Morphee

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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