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

Sponsor:

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

History of Changes

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 SYNGAP1-related intellectual disability

MedlinePlus related topics: Down Syndrome Sleep Apnea

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 (Adult, Senior)
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

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:

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.


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 Syndrome Apnea Sleep Apnea Syndromes 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

ClinicalTrials.gov processed this record on September 28, 2016

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