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CompletedNCT00394290MorpheeUpdated Mar 26, 2019

Down Syndrome and Continuous Positive Pressure Therapy

An interventional study of Continuous Positive Pressure in Down Syndrome and Obstructive Sleep Apnea Syndrome, sponsored by Institut Jerome Lejeune. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Institut Jerome Lejeune · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Down Syndrome
  • Obstructive Sleep Apnea Syndrome

Keywords

  • Down Syndrome
  • Obstructive Sleep Apnea Syndrome
  • Continuous Positive Pressure
  • Hypersomnia
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 31 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Institut Jerome Lejeune is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Down Syndrome patients with an Obstructive Sleep Apnea Syndrome
  • more than 18 years old

Exclusion criteria

Exclusion Criteria:

  • predictable non-compliance of device
  • non-compensated cardiopathy
  • non-stable thyroxin treatment
  • non-stable diabetes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    PPC

    Night time device for positive pulmonary pressure

    Device: Continuous Positive Pressure

Interventions

  • DeviceContinuous Positive Pressure

    Nighttime continuous positive pressure device, to be used every day

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Tolerability

    Time frame: 0, 3 and 12 months

07

Study locations

1 site
  • Institut Jerome Lejeune
    Paris, 75015, France
08

References and documents

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. doi: 10.3104/reports.138. PubMed 14502839 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00394290
Lead sponsor
Institut Jerome Lejeune
Collaborators
Fondation Jérôme Lejeune
Responsible party
Sponsor
First posted
Nov 1, 2006
Start date
Nov 16, 2006
Primary completion
Oct 31, 2012
Completion
Dec 31, 2012
Last update
Mar 26, 2019

Study contacts

Martine Conte, M.D.
principal investigator · Institut Jerome Lejeune
Franck STURTZ, M.D.
study director · Institut Jerome Lejeune

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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