Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT06326424

Conditions

Delirium

Dementia

Hospital Acquired Condition

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Empatica EmbracePlus

Study Details

Brief summary:

Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.

Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.

The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools.

Conditions

Delirium

Dementia

Hospital Acquired Condition

Study ID

NCT06326424

Start date

Apr 10, 2024

Status verified date

Mar, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adults patients 65+ years old with a known diagnosis of dementia or medical team highly suspects or confirms dementia this visit.
  • Emergency Department visit and/or hospitalization anticipated to last >4 more hours from the time of enrollment.

Exclusion Criteria:

  • Intubation/mechanical ventilation
  • Patients undergoing a procedure requiring sedation
  • Patients who cannot consent due to cognitive impairment and do not have a legally authorized representative or caregiver present.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational DELIRIUM cohort

We will follow up to 60 adults 65+ years old with dementia or suspected dementia who are likely to be in the emergency department, observation unit, or hospital for 48 hours. We will follow them for up to 48 hours while they wear an FDA approved biosensor watch and perform delirium checks.

Interventions

Empatica EmbracePlus

wear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity.

Primary outcome measure

  • Proportion of participants who develop delirium [ Time Frame: over the 48 hours of study participation ]

Central Contacts and Locations

Central contacts

Michael Hill, RN

michael.hill@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Apr 3, 2025

Last verified

Mar, 2025

Keywords

  • emergency department
  • delirium
  • older adults
  • dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-04-03.