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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Institut Jerome Lejeune.
Recruitment status was:  Recruiting
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune Identifier:
First received: October 31, 2006
Last updated: October 18, 2012
Last verified: October 2012
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

Condition Intervention
Down Syndrome
Obstructive Sleep Apnea Syndrome
Device: Continuous Positive Pressure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients

Resource links provided by NLM:

Further study details as provided by Institut Jerome Lejeune:

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

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 0, 3 and 12 months ]

Estimated Enrollment: 30
Study Start Date: November 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PPC
Night time device for positive pulmonary pressure
Device: Continuous Positive Pressure
Nighttime continuous positive pressure device, to be used every day


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00394290

Contact: Yann Grattau, M.D. +33 1 56586325
Contact: Celine duBoispean +33 1 56586328

Institut Jerome Lejeune Recruiting
Paris, France, 75015
Contact: Yann Grattau, M.D.    +33 1 56586325   
Contact: Celine duBoispean    +33 1 56586328   
Principal Investigator: Martine Conte, M.D.         
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
Principal Investigator: Martine Conte, M.D. Institut Jerome Lejeune
Study Director: Franck STURTZ, M.D. Institut Jerome Lejeune
  More Information

Responsible Party: Institut Jerome Lejeune Identifier: NCT00394290     History of Changes
Other Study ID Numbers: IJL-PPC-EP02
Study First Received: October 31, 2006
Last Updated: October 18, 2012

Keywords provided by Institut Jerome Lejeune:
Down Syndrome
Obstructive Sleep Apnea Syndrome
Continuous Positive Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Down Syndrome
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn processed this record on May 25, 2017