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Clinical Trials/NCT00951730
NCT00951730
Completed
Not Applicable

Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome

Centre Hospitalier Universitaire de Saint Etienne3 sites in 1 country97 target enrollmentFebruary 2010
ConditionsDown Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Down Syndrome
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
97
Locations
3
Primary Endpoint
Apnea / hypopnea events index determined by reading the complete polysomnography (review reference) and apnea / hypopnoea events index determined by the simplified five parameters of the polysomnography
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of the upper airway, but also of central origin. According to published data, sleep apnea may occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart disease, accident due to day sleepiness, fatigue. This condition is treatable in people with Down syndrome, as it is in ordinary people.

Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In addition, data regarding age of apparition of this complication are missing, making repeated screening necessary.

Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it is time consuming and sleep departments are heavily busy.

Detailed Description

The main objective of our study is to evaluate an easier screening strategy combining questionnaire and overnight recording of few data, compared to polysomnography. We hope our strategy will permit regular screening for people with Down syndrome, helping us to draw guidelines for the survey of sleep apnea in this population.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
February 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Down syndrome
  • Patient (or parents of children) affiliated in a Social Regimen
  • Written consent signed (by parents for the children)

Exclusion Criteria

  • Severe heart failure
  • Insufficient autonomy
  • Diagnosis of insanity, or behavioural problems

Outcomes

Primary Outcomes

Apnea / hypopnea events index determined by reading the complete polysomnography (review reference) and apnea / hypopnoea events index determined by the simplified five parameters of the polysomnography

Time Frame: At 15 days after enroling

Secondary Outcomes

  • Questionnaire on sleep(At inclusion and at the end (18 months))
  • Psychometric tests(At inclusion and at the end (18 months))

Study Sites (3)

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