Obstructive Sleep Apnea Syndrome (OSA) and Getemed

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT01720823
• Date of registration: 31/10/2012
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Obstructive Sleep Apnea Syndrome (OSA) and Getemed GETEMED
• Scientific title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
• Date of first enrolment: October 2012
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01720823
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Patricia FRANCO, MD
• Affiliation: Hospices Civils de Lyon- Hôpital Femme Mère Enfant

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or
admitted for intense snoring or suspected sleep apnea

- Parents must have signed the inform consent form and be covered by the National
Health Insurance Program.

Exclusion Criteria:

- Parents opposed to the study.



Age minimum: 2 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sleep Apnea, Obstructive

Intervention(s)

Device: standard polysomnography (BRAINNET II)

Device: home polysomnography (GETEMED)

Primary Outcome(s)

Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. [Time Frame: 1 night]

Secondary Outcome(s)

To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography. [Time Frame: 1 night]

Secondary ID(s)

2009.589

Source(s) of Monetary Support

Please refer to primary and secondary sponsors