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NCT03067233 Clinical Trial

Automated Embedded Polysomnography (AEP)

Healthy Clinical Trial

— AEP  

Official title:
Automated Embedded Polysomnography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03067233
Other study ID # ADOREPS_6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2016
Est. completion date April 8, 2016

Study information
Verified date February 2017
Source Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To develop and validate a reliable automatic analysis of the signals recorded during a polysomnography.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date April 8, 2016
Est. primary completion date April 8, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Insured by social security - Speak french Exclusion Criteria: - Sleep disorder - Neurologic, respiratory or cardiac disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Polysomnography
Complete polysomnography with : Electroencephalogry, electro-oculography, surface electromyography (chin muscle, anterior tibial muscles), nasal pressure, respiratory movements (plethysmography of thoracic and abdominal inductance), pulse oximetry and electrocardiography.

Locations
Country Name City State
France Service des pathologies du sommeil - GH Pitié-Slapêtrière Paris

Sponsors (1)
Lead Sponsor Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the automatic analysis Comparison between polysomnographic analysis by two expert physicians and an automatic analysis 72 hour
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