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

NCT ID: NCT00951730

Last Updated: 2015-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-02-28

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.

Conditions

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Down Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Down syndrome

Adult and children with Down syndrome.

Polysomnography

Intervention Type OTHER

Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.

Interventions

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Polysomnography

Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.

Intervention Type OTHER

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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benedicte De Freminville, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Grenoble

Grenoble, , France

Site Status

Hospices Civiles de lyon

Lyon, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2008-A01273-52

Identifier Type: OTHER

Identifier Source: secondary_id

0808017

Identifier Type: -

Identifier Source: org_study_id

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