Digital and Plasma Biomarkers in Delirium

Delirium Evaluation With Longitudinal Tau Assessment

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07694206

Acronym

DELTA

Enrollment

100

Registered

2026-07-09

Start date

2026-05-28

Completion date

2027-12-31

Last updated

2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Delirium in the Intensive Care Unit, Sleep Quality

Keywords

Sleep in the ICU, Delirium in the ICU, Delirium biomarkers

Brief summary

The goal of this observational study is to learn if there are potential digital and plasma-based biomarkers that could help detect, predict, and prognosticate delirium in older adult patients who are admitted to the intensive care unit (ICU). The main question DELTA aims to answer is: Can digital biometrics predict and detect delirium in older adult ICU patients? Do biomarkers of neurodegeneration fluctuate in ICU patients in such a way that delrium could potentially be predicted? Participants admitted o the ICU will wear a digital device to collect biometric data and will have serial plasma samples collected during ICU admission and patients will be also assessed for delirium daily by study staff.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Admitted to the intensive care unit * Able to consent or have a legally authorized representative consent on their behalf * English speaker * Expected ICU stay of 48 hours or more

Exclusion criteria

* Advanced dementia * End stage liver disease * Renal replacement therapy * Structural brain injury, including but not limited to traumatic brain injury, cerebrovascular accident and intracranial hemorrhage,

Design outcomes

Primary

Measure	Time frame	Description
Delirium	Between enrollment and ICU discharge, up to a maximum of 10 days.	Delirium incidence as assessed by the CAM-ICU instrument.

Secondary

Measure	Time frame	Description
Sleep Duration	Between enrollment and ICU discharge up to a maximum 10 days in the ICU.	Daily total sleep duration as measured by actigraphy
Sleep fragmentation	Nightly between enrollment and ICU discharge, up to a maximum of 10 days.	Nightly sleep fragmentation as measured by actigraphy
Circadian activity rhythm disruption	Daily between enrollment and ICU discharge, up to a maximum of 10 days.	Using daily activity/temperature/heart rate, circadian activity rhythms will be assessed for goodness of fit to a cosinor curve.

Countries

United States

Contacts

CONTACTStuti Jaiswal, MD, PhD

jaiswal.stuti@scrippshealth.org858-554-9100

Outcome results