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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

This study is currently recruiting participants.
Verified October 2012 by Institut Jerome Lejeune
Sponsor:
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune
ClinicalTrials.gov Identifier:
NCT00394290
First received: October 31, 2006
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 0, 3 and 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT00394290     History of Changes
Other Study ID Numbers: IJL-PPC-EP02, Morphee
Study First Received: October 31, 2006
Last Updated: October 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on June 18, 2013