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NCT Number: NCT00951730

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Questionnaire on sleep

    Time frame: At inclusion and at the end (18 months)

  2. Psychometric tests

    Time frame: At inclusion and at the end (18 months)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: SAOS/T21

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2009
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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