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CompletedNCT04797052VEEGilanceUpdated Mar 30, 2023

EEG Detection of Delirium

An interventional study of Prefrontal EEG (VEEGix by NeuroServo) in Post Operative Delirium, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 65 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Not applicable
Ages
65 Years to 120 Years
Sex
All
01

Study summary

VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.

Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.

02

Conditions studied

  • Post Operative Delirium

Keywords

  • Post operative delirium
  • Older Adults
  • Electroencephalography
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 234 is above the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 65 years and older
  • Had a orthopedic or digestive surgery
  • Good undersanding of French or English
  • Consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • History of seizure or epilepsia
  • Structural brain damage
  • intelectual deiciency
  • Severe major neurocognitive disorder
  • incapacity to respond to the questionnaire
  • Hospitalised in intensive care or intubated
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
234 participants (actual)

Study arms

  • Experimental
    Post operative patients

    Post operative patient in orthopedic and digestive surgery

    Device: Prefrontal EEG (VEEGix by NeuroServo)

Interventions

  • DevicePrefrontal EEG (VEEGix by NeuroServo)

    Prefrontal EEG reading

06

What researchers measure

Primary outcomes

  1. Difference of relative power of delta and theta brain waves

    Difference between group with and without delirium

    Time frame: up to five days after the operation

Secondary outcomes

  1. Difference of relative power of beta and alpha brain waves

    Difference between group with and without delirium

    Time frame: up to five days after the operation

  2. describe the presence of artefacts

    Examine the EEG reading for artefacts

    Time frame: up to five days after the operation

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Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04797052
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
TransMedTech Institute
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Apr 5, 2021
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023
Last update
Mar 30, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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