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NCT Number: NCT07694206

Digital and Plasma Biomarkers in Delirium

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.

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Key information

Conditions

Critical Illness Delirium in the Intensive Care Unit Disease Attributes Dyssomnias Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Green Hospital, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. Delirium

    Time frame: Between enrollment and ICU discharge, up to a maximum of 10 days.

    Delirium incidence as assessed by the CAM-ICU instrument.

Secondary outcomes

  1. Sleep Duration

    Time frame: Between enrollment and ICU discharge up to a maximum 10 days in the ICU.

    Daily total sleep duration as measured by actigraphy

  2. Sleep fragmentation

    Time frame: Nightly between enrollment and ICU discharge, up to a maximum of 10 days.

    Nightly sleep fragmentation as measured by actigraphy

  3. Circadian activity rhythm disruption

    Time frame: 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.

Other outcomes

  1. Delirium duration

    Time frame: between enrollment and ICU discharge up to a maximum of 10 days

    As measured by CAM-ICU

Study contacts

Contact information is provided by the study sponsor or research team.

Stuti Jaiswal, MD, PhD

CONTACT

[email protected]

858-554-9100

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

Delirium Evaluation With Longitudinal Tau Assessment

Acronym: DELTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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