NCT00394290

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
15 days until next milestone

Study Start

First participant enrolled

November 16, 2006

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
Last Updated

March 26, 2019

Status Verified

October 1, 2012

Enrollment Period

6 years

First QC Date

October 31, 2006

Last Update Submit

March 23, 2019

Conditions

Down SyndromeObstructive Sleep Apnea Syndrome

Keywords

Down SyndromeObstructive Sleep Apnea SyndromeContinuous Positive PressureHypersomnia

Outcome Measures

Primary Outcomes (1)

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

    0 and 3 months

Secondary Outcomes (1)

  • Tolerability

    0, 3 and 12 months

Study Arms (1)

PPC

EXPERIMENTAL

Night time device for positive pulmonary pressure

Device: Continuous Positive Pressure

Interventions

Continuous Positive PressureDEVICE

Nighttime continuous positive pressure device, to be used every day

PPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jerome Lejeune

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 14502839BACKGROUND

MeSH Terms

Conditions

Down SyndromeSleep Apnea, ObstructiveDisorders of Excessive Somnolence

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Martine Conte, M.D.

    Institut Jerome Lejeune

    PRINCIPAL INVESTIGATOR

  • Franck STURTZ, M.D.

    Institut Jerome Lejeune

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

November 16, 2006

Primary Completion

October 31, 2012

Study Completion

December 31, 2012

Last Updated

March 26, 2019

Record last verified: 2012-10

Locations

FR(1)