Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06172491

Conditions

Intensive Care Unit Delirium

Encephalopathy

Delirium

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients >50 years of age.

The main questions it aims to answer are:

  • Is the trained convolutional neural network able to reliably measure delirium severity.
  • Is the Passive Digital Marker able to accurately measure delirium severity
  • Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers).

Participants will:

  • Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU).
  • Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.

Conditions

Intensive Care Unit Delirium

Encephalopathy

Delirium

Study ID

NCT06172491

Start date

Jan 15, 2023

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria: • Age >50;

  • Estimated length of stay >24 hours in ICU; and
  • Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.

Exclusion Criteria:

  • Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
  • Admitted for acute neuronal injury
  • Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

No Delirium Severity

Patients who did not experience a level of delirium severity (subsyndromal, mild, moderate, severe)

Delirium Severity

Patients who did experience a level of delirium severity (subsyndromal, mild, moderate, severe)

Primary outcome measure

  • Delirium Severity [ Time Frame: 12-48 months ]
  • Acceptability of passive digital marker for delirium severity [ Time Frame: 48 months - 60 months ]
  • Usability of passive digital marker for delirium severity [ Time Frame: 48 months - 60 months ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Heidi Lindroth, Ph.D., R.N.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Delirium
  • Severity
  • Digital marker
  • Computer Vision
  • Artificial Intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-08.