Recruiting

Digital Biomarkers

Sponsor:

Scripps Health

Code:

NCT07694206

Conditions

Critical Illness

Delirium in the Intensive Care Unit

Sleep Quality

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

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

Critical Illness

Delirium in the Intensive Care Unit

Sleep Quality

Study ID

NCT07694206

Start date

May 28, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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,

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Delirium [ Time Frame: Between enrollment and ICU discharge, up to a maximum of 10 days. ]

Central Contacts and Locations

Central contacts

Stuti Jaiswal, MD, PhD

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

Locations

Scripps Memorial La Jolla Hospital

Recruiting

San Diego, California, United States, 92117

Contacts

Stuti J Jaiswal, MD, PhD

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

jaiswal.stuti@scrippshealth.org

Principal Investigator:

Stuti J Jaiswal, MD, PhD

More Information

Sponsor

Scripps Health

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Sleep in the ICU
  • Delirium in the ICU
  • Delirium biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2026-07-09.