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RecruitingNCT07694206DELTAUpdated Jul 9, 2026

Digital and Plasma Biomarkers in Delirium

An observational study in Critical Illness, Delirium in the Intensive Care Unit and Sleep Quality, sponsored by Scripps Health. Recruiting at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Scripps Health · Observational

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
65 Years and older
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • Sleep in the ICU
  • Delirium in the ICU
  • Delirium biomarkers
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In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 100 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Scripps Health is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill older adults.

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

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,
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Delirium

    Delirium incidence as assessed by the CAM-ICU instrument.

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

Secondary outcomes

  1. Sleep Duration

    Daily total sleep duration as measured by actigraphy

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

  2. Sleep fragmentation

    Nightly sleep fragmentation as measured by actigraphy

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

  3. Circadian activity rhythm disruption

    Using daily activity/temperature/heart rate, circadian activity rhythms will be assessed for goodness of fit to a cosinor curve.

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

Other outcomes

  1. Delirium duration

    As measured by CAM-ICU

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

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Study locations

1 of 2 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — Deidentified participant data will be shared upon reasonable request from the principal investigator. A data dictionary will be provided.

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07694206
Lead sponsor
Scripps Health
Responsible party
Stuti Jaiswal (Faculty Hospitalist, Scripps Health) — Principal investigator
First posted
Jul 9, 2026
Start date
May 28, 2026
Primary completion
Oct 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

Stuti Jaiswal, MD, PhD
Contact
jaiswal.stuti@scrippshealth.org
858-554-9100

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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