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Down Syndrome and Continuous Positive Pressure Therapy (Morphee)

Primary Purpose

Down Syndrome, Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous Positive Pressure
Sponsored by
Institut Jerome Lejeune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down Syndrome, Obstructive Sleep Apnea Syndrome, Continuous Positive Pressure, Hypersomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jerome Lejeune

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PPC

Arm Description

Night time device for positive pulmonary pressure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerability

Full Information

First Posted
October 31, 2006
Last Updated
March 23, 2019
Sponsor
Institut Jerome Lejeune
Collaborators
Fondation Jérôme Lejeune
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1. Study Identification

Unique Protocol Identification Number
NCT00394290
Brief Title
Down Syndrome and Continuous Positive Pressure Therapy
Acronym
Morphee
Official Title
Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 16, 2006 (Actual)
Primary Completion Date
October 31, 2012 (Actual)
Study Completion Date
December 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Jerome Lejeune
Collaborators
Fondation Jérôme Lejeune

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Obstructive Sleep Apnea Syndrome
Keywords
Down Syndrome, Obstructive Sleep Apnea Syndrome, Continuous Positive Pressure, Hypersomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPC
Arm Type
Experimental
Arm Description
Night time device for positive pulmonary pressure
Intervention Type
Device
Intervention Name(s)
Continuous Positive Pressure
Intervention Description
Nighttime continuous positive pressure device, to be used every day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Tolerability
Time Frame
0, 3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Conte, M.D.
Organizational Affiliation
Institut Jerome Lejeune
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franck STURTZ, M.D.
Organizational Affiliation
Institut Jerome Lejeune
Official's Role
Study Director
Facility Information:
Facility Name
Institut Jerome Lejeune
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
14502839
Citation
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.
Results Reference
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Down Syndrome and Continuous Positive Pressure Therapy

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