Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome (SAOS/T21)
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|ClinicalTrials.gov Identifier: NCT00951730|
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : July 7, 2015
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.
|Condition or disease||Intervention/treatment|
|Down Syndrome||Other: Polysomnography|
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 Type :||Observational|
|Actual Enrollment :||97 participants|
|Official Title:||Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome|
|Study Start Date :||February 2010|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Adult and children with Down syndrome.
Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.
- 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 ]
- Questionnaire on sleep [ Time Frame: At inclusion and at the end (18 months) ]
- Psychometric tests [ Time Frame: At inclusion and at the end (18 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951730
|CHU de Grenoble|
|Grenoble, France, 38000|
|Hospices Civiles de lyon|
|Lyon, France, 69000|
|CHU de Saint-Etienne|
|Saint-etienne, France, 42055|
|Principal Investigator:||Benedicte De Freminville, MD||CHU de Saint-Etienne|