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CompletedNCT03067233AEPUpdated Apr 8, 2024

Automated Embedded Polysomnography (AEP)

An interventional study of Polysomnography in Healthy, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Insured by social security
  • Speak french

Exclusion criteria

Exclusion Criteria:

  • Sleep disorder
  • Neurologic, respiratory or cardiac disease
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Polysomnography

    Three polysomnographic recordings will be made on 3 consecutive nights with Electroencephalogry.

    Other: Polysomnography

Interventions

  • OtherPolysomnography

    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.

05

What researchers measure

Primary outcomes

  1. Evaluation of the automatic analysis

    Comparison between polysomnographic analysis by two expert physicians and an automatic analysis

    Time frame: 72 hour

06

Study locations

1 site
  • Service des pathologies du sommeil - GH Pitié-Slapêtrière
    Paris, 75013, France
07

Registry details

Key details

Study ID
NCT03067233
Lead sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Responsible party
Sponsor
First posted
Mar 1, 2017
Start date
Apr 5, 2016
Primary completion
Apr 8, 2016
Completion
Apr 8, 2016
Last update
Apr 8, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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