Skip to main content
OpenTrials
Completed

NCT Number: NCT00394290

Down Syndrome and Continuous Positive Pressure Therapy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Down Syndrome Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Excessive Somnolence Dyssomnias Genetic Diseases, Inborn Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Obstructive Sleep Apnea Syndrome Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jerome Lejeune

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Pressure

Device

Nighttime continuous positive pressure device, to be used every day

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

Sponsors and collaborators

Lead sponsor

Institut Jerome Lejeune

Other

Collaborators

  • Fondation Jérôme Lejeune

Registry information

Official study title

Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients

Acronym: Morphee

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2006
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.