Down Syndrome and Continuous Positive Pressure Therapy | NCT00394290

Studies
Down Syndrome and Continuous Positive Pressure Therapy

NCT00394290

Sponsor

Institut Jerome Lejeune

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Down Syndrome
Obstructive Sleep Apnea Syndrome

Interventions

Continuous Positive Pressure

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Morphee

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2006Actual

Primary Completion Date

Oct 31, 2012Actual

Completion Date

Dec 31, 2012Actual

First Submitted Date

Oct 31, 2006

First Submission Date that Met QC Criteria

Oct 31, 2006

First Posted Date

Nov 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2019

Last Update Posted Date

Mar 26, 2019Actual

Name	Class
Fondation Jérôme Lejeune	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PPC	Experimental	Night time device for positive pulmonary pressure	Device: Continuous Positive Pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Positive Pressure	Device	Nighttime continuous positive pressure device, to be used every day	PPC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months)		0 and 3 months

Secondary Outcomes

Measure	Description	Time Frame
Tolerability		0, 3 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martine Conte, M.D.	Institut Jerome Lejeune	Principal Investigator
Franck STURTZ, M.D.	Institut Jerome Lejeune	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jerome Lejeune		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14502839	Background	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. doi: 10.3104/reports.138.

ID	Term
D004314	Down Syndrome
D020181	Sleep Apnea, Obstructive
D006970	Disorders of Excessive Somnolence

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics