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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00951730
Acronym
SAOS/T21
Enrollment
97
Registered
2009-08-04
Start date
2010-02-28
Completion date
2015-02-28
Last updated
2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Down Syndrome, Adult, Children, Sleep apnea, Sleep hypopnea, Polysomnography

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.

Interventions

OTHERPolysomnography

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

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 polysomnographyAt 15 days after enroling

Secondary

MeasureTime frame
Questionnaire on sleepAt inclusion and at the end (18 months)
Psychometric testsAt inclusion and at the end (18 months)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026