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

Down Syndrome Clinical Trial

— SAOS/T21  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951730
• Other study ID #: 0808017
• Secondary ID: 2008-A01273-52
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: July 3, 2015
• Start date: February 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	Hospices Civiles de lyon	Lyon
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At 15 days after enroling	No
Secondary	Questionnaire on sleep		At inclusion and at the end (18 months)	No
Secondary	Psychometric tests		At inclusion and at the end (18 months)	No