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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

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.
ClinicalTrials.gov Identifier: NCT00394290
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Fondation Jérôme Lejeune
Information provided by (Responsible Party):
Institut Jerome Lejeune

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 1, 2006
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE November 16, 2006
Actual Primary Completion Date October 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) [ Time Frame: 0 and 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
Scores on psychometrical and dementia scales after 3 months treatment (and if possible, after 12 months)
Change History Complete list of historical versions of study NCT00394290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2009)
Tolerability [ Time Frame: 0, 3 and 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Down Syndrome and Continuous Positive Pressure Therapy
Official Title  ICMJE Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients
Brief Summary The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Down Syndrome
  • Obstructive Sleep Apnea Syndrome
Intervention  ICMJE Device: Continuous Positive Pressure
Nighttime continuous positive pressure device, to be used every day
Study Arms  ICMJE Experimental: PPC
Night time device for positive pulmonary pressure
Intervention: Device: Continuous Positive Pressure
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2019)
31
Original Enrollment  ICMJE
 (submitted: October 31, 2006)
30
Actual Study Completion Date  ICMJE December 31, 2012
Actual Primary Completion Date October 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394290
Other Study ID Numbers  ICMJE IJL-PPC-EP02
Morphee
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Jerome Lejeune
Study Sponsor  ICMJE Institut Jerome Lejeune
Collaborators  ICMJE Fondation Jérôme Lejeune
Investigators  ICMJE
Principal Investigator: Martine Conte, M.D. Institut Jerome Lejeune
Study Director: Franck STURTZ, M.D. Institut Jerome Lejeune
PRS Account Institut Jerome Lejeune
Verification Date October 2012

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