Down Syndrome and Continuous Positive Pressure Therapy (Morphee)
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ClinicalTrials.gov Identifier: NCT00394290 |
Recruitment Status
: Unknown
Verified October 2012 by Institut Jerome Lejeune.
Recruitment status was: Recruiting
First Posted
: November 1, 2006
Last Update Posted
: October 19, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Down Syndrome Obstructive Sleep Apnea Syndrome | Device: Continuous Positive Pressure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 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 |
Study Start Date : | November 2006 |
Estimated Primary Completion Date : | October 2012 |
Estimated Study Completion Date : | December 2012 |
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
|
- Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) [ Time Frame: 0 and 3 months ]
- Tolerability [ Time Frame: 0, 3 and 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Yann Grattau, M.D. | +33 1 56586325 | yann.grattau@institutlejeune.org | |
Contact: Celine duBoispean | +33 1 56586328 | celine.du.boispean@institutlejeune.org |
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. |
Principal Investigator: | Martine Conte, M.D. | Institut Jerome Lejeune | |
Study Director: | Franck STURTZ, M.D. | Institut Jerome Lejeune |
Publications:
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: | October 19, 2012 |
Last Verified: | October 2012 |
Keywords provided by Institut Jerome Lejeune:
Down Syndrome Obstructive Sleep Apnea Syndrome Continuous Positive Pressure Hypersomnia |
Additional relevant MeSH terms:
Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Down Syndrome 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 |