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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394290
First Posted: November 1, 2006
Last Update Posted: October 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune
October 31, 2006
November 1, 2006
October 19, 2012
November 2006
October 2012   (Final data collection date for primary outcome measure)
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) [ Time Frame: 0 and 3 months ]
Scores on psychometrical and dementia scales after 3 months treatment (and if possible, after 12 months)
Complete list of historical versions of study NCT00394290 on ClinicalTrials.gov Archive Site
Tolerability [ Time Frame: 0, 3 and 12 months ]
Tolerability
Not Provided
Not Provided
 
Down Syndrome and Continuous Positive Pressure Therapy
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Down Syndrome
  • Obstructive Sleep Apnea Syndrome
Device: Continuous Positive Pressure
Nighttime continuous positive pressure device, to be used every day
Experimental: PPC
Night time device for positive pulmonary pressure
Intervention: Device: Continuous Positive Pressure
Resta O, Barbaro MP, Giliberti T, Caratozzolo G, Cagnazzo MG, Scarpelli F, Nocerino MC. Sleep related breathing disorders in adults with Down syndrome. Downs Syndr Res Pract. 2003 Aug;8(3):115-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
December 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00394290
IJL-PPC-EP02
Morphee
No
Not Provided
Not Provided
Institut Jerome Lejeune
Institut Jerome Lejeune
Fondation Jérôme Lejeune
Principal Investigator: Martine Conte, M.D. Institut Jerome Lejeune
Study Director: Franck STURTZ, M.D. Institut Jerome Lejeune
Institut Jerome Lejeune
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP