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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

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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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 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
Actual Study Start Date : November 16, 2006
Actual Primary Completion Date : October 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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France
Institut Jerome Lejeune
Paris, France, 75015
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
Investigators
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Principal Investigator: Martine Conte, M.D. Institut Jerome Lejeune
Study Director: Franck STURTZ, M.D. Institut Jerome Lejeune

Publications:
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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: March 26, 2019
Last Verified: October 2012

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

Additional relevant MeSH terms:
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Syndrome
Sleep Apnea Syndromes
Down Syndrome
Apnea
Sleep Apnea, Obstructive
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