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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Down Syndrome

Intervention / Treatment
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* Other: Polysomnography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Down syndrome<br>Adult and children with Down syndrome. | Other: Polysomnography<br>* Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on sleep |  | At inclusion and at the end (18 months) | 
| Psychometric tests |  | At inclusion and at the end (18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Down Syndrome, Adult, Children, Sleep apnea, Sleep hypopnea, Polysomnography