Digital and Plasma Biomarkers in Delirium

NCT07694206 | Recruiting

• 1 other identifier: IRB-25-8641
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Sleep in the ICU; Delirium in the ICU; Delirium biomarkers

Outcome Measures

Primary Outcomes (1)

• Delirium

  Delirium incidence as assessed by the CAM-ICU instrument.

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

Secondary Outcomes (3)

• Sleep Duration

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

• Sleep fragmentation

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

• Circadian activity rhythm disruption

  Daily between enrollment and ICU discharge, up to a maximum of 10 days.

Other Outcomes (1)

• Delirium duration

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

Study Arms (1)

DELTA Cohort

This is the main cohort in which all participants will be enrolled in. These individuals are older adults admitted to the intensive care unit (ICU) with an expected stay of at least 48 hours. Broadly, individuals cannot have advanced dementia at baseline, have liver cirrhosis or be on any kind of renal replacement therapy.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill older adults.

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (2)

Scripps Green Hospital

La Jolla, California, 92037, United States

NOT YET RECRUITING

Scripps Memorial La Jolla Hospital

San Diego, California, 92117, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Critical Illness; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Stuti Jaiswal, MD, PhD

CONTACT

858-554-9100; jaiswal.stuti@scrippshealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Hospitalist

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 2028 to December 2033
• Access Criteria: Data will be provided via a secure served based on reasonable email request to th PI.

Locations

US (2)