Automated Embedded Polysomnography (AEP) (AEP)

Automated Embedded Polysomnography

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Polysomnography

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service des pathologies du sommeil - GH Pitié-Slapêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Insured by social security
• Speak french

Exclusion Criteria:

• Sleep disorder
• Neurologic, respiratory or cardiac disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polysomnography; Three polysomnographic recordings will be made on 3 consecutive nights with Electroencephalogry.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the automatic analysis	Comparison between polysomnographic analysis by two expert physicians and an automatic analysis	72 hour

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2016
• Primary Completion (Actual): April 8, 2016
• Study Completion (Actual): April 8, 2016

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ADOREPS_6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No