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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

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ClinicalTrials.gov Identifier: NCT00394290
Recruitment Status : Unknown
Verified October 2012 by Institut Jerome Lejeune.
Recruitment status was:  Recruiting
First Posted : November 1, 2006
Last Update Posted : October 19, 2012
Sponsor:
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

Condition or disease Intervention/treatment Phase
Down Syndrome Obstructive Sleep Apnea Syndrome Device: Continuous Positive Pressure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Tolerability [ Time Frame: 0, 3 and 12 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394290


Contacts
Contact: Yann Grattau, M.D. +33 1 56586325 yann.grattau@institutlejeune.org
Contact: Celine duBoispean +33 1 56586328 celine.du.boispean@institutlejeune.org

Locations
France
Institut Jerome Lejeune Recruiting
Paris, France, 75015
Contact: Yann Grattau, M.D.    +33 1 56586325    yann.grattau@institutlejeune.org   
Contact: Celine duBoispean    +33 1 56586328    celine.du.boispean@institutlejeune.org   
Principal Investigator: Martine Conte, M.D.         
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
Investigators
Principal Investigator: Martine Conte, M.D. Institut Jerome Lejeune
Study Director: Franck STURTZ, M.D. Institut Jerome Lejeune
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT00394290     History of Changes
Other Study ID Numbers: IJL-PPC-EP02
Morphee
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012

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

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