Down Syndrome and Continuous Positive Pressure Therapy (Morphee)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Institut Jerome Lejeune.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Institut Jerome Lejeune
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
CASK-related intellectual disability
Down syndrome
tetrasomy 18p
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394290
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 Sleep Apnea Syndromes Sleep Apnea, Obstructive Syndrome Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Disease Dyssomnias |
Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Respiration Disorders Respiratory Tract Diseases Sleep Disorders Sleep Disorders, Intrinsic |
ClinicalTrials.gov processed this record on March 03, 2015