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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
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

August 3, 2009
August 4, 2009
July 7, 2015
February 2010
February 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00951730 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Questionnaire on sleep [ Time Frame: At inclusion and at the end (8 months) ]
  • Psychometric tests [ Time Frame: At inclusion and at the end (8 months) ]
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Down syndrome
Down Syndrome
Other: Polysomnography
Polysomnography is the method of choice for the diagnosis of sleep apnea. This test lasts for one night in hospital.
Down syndrome
Adult and children with Down syndrome.
Intervention: Other: Polysomnography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
120
February 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00951730
0808017
2008-A01273-52 ( Other Identifier: AFSSAPS )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Benedicte De Freminville, MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
July 2015