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

Completed

• Conditions: Down Syndrome
• Interventions: Other: Polysomnography

• Registration Number: NCT00951730
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Study Start: 2010-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Down syndrome	Polysomnography	Adult and children with Down syndrome.

Primary Outcome Measures

Name	Time	Method
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	At 15 days after enroling

Secondary Outcome Measures

Name	Time	Method
Questionnaire on sleep	At inclusion and at the end (18 months)
Psychometric tests	At inclusion and at the end (18 months)

Trial Locations

Locations (3)

CHU de Grenoble; 🇫🇷 Grenoble, France

Hospices Civiles de lyon; 🇫🇷 Lyon, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France