NCT03067233

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2016

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
Last Updated

April 8, 2024

Status Verified

February 1, 2017

Enrollment Period

3 days

First QC Date

February 24, 2017

Last Update Submit

April 5, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the automatic analysis

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

    72 hour

Study Arms (1)

Polysomnography

EXPERIMENTAL

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

Other: Polysomnography

Interventions

PolysomnographyOTHER

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.

Polysomnography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insured by social security
  • Speak french

You may not qualify if:

  • Sleep disorder
  • Neurologic, respiratory or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des pathologies du sommeil - GH Pitié-Slapêtrière

Paris, 75013, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 1, 2017

Study Start

April 5, 2016

Primary Completion

April 8, 2016

Study Completion

April 8, 2016

Last Updated

April 8, 2024

Record last verified: 2017-02

Locations

FR(1)