Critical IllnessDELTANCT07694206
Digital and Plasma Biomarkers in Delirium
An observational study of Critical Illness and Delirium in the Intensive Care Unit, run by Scripps Health at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Critical Illness, Delirium in the Intensive Care Unit, Sleep Quality
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Critically ill older adults.
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Scripps Green Hospital
La Jolla, California, 92037
Stuti Jaiswal, MD, PhD, 858-554-9100, jaiswal.stuti@scrippshealth.org
- Recruiting
Scripps Memorial La Jolla Hospital
San Diego, California, 92117
Stuti J Jaiswal, MD, PhD, 858-554-9100, jaiswal.stuti@scrippshealth.org
jaiswal.stuti@scrippshealth.org
About this study
Official title: Delirium Evaluation With Longitudinal Tau Assessment
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.
- Keywords
- Sleep in the ICU, Delirium in the ICU, Delirium biomarkers
- Medical subject headings
- Critical Illness, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirium incidence as assessed by the CAM-ICU instrument.
Measured: Between enrollment and ICU discharge, up to a maximum of 10 days.
Secondary outcomes (3)
Sleep Duration
Daily total sleep duration as measured by actigraphy
Measured: Between enrollment and ICU discharge up to a maximum 10 days in the ICU.
Sleep fragmentation
Nightly sleep fragmentation as measured by actigraphy
Measured: Nightly between enrollment and ICU discharge, up to a maximum of 10 days.
Circadian activity rhythm disruption
Using daily activity/temperature/heart rate, circadian activity rhythms will be assessed for goodness of fit to a cosinor curve.
Measured: Daily between enrollment and ICU discharge, up to a maximum of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start28 May 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuti Jaiswal, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694206
- Sponsor's protocol ID
- IRB-25-8641
- Acronym
- DELTA
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be shared upon reasonable request from the principal investigator. A data dictionary will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Evaluation With Longitudinal Tau Assessment
- ClinicalTrials.gov ID
- NCT07694206
- Acronym / sponsor ID
- DELTA / IRB-25-8641
- Keywords
- Sleep in the ICU, Delirium in the ICU, Delirium biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Critically ill older adults.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium
Time frame: Between enrollment and ICU discharge, up to a maximum of 10 days.
Delirium incidence as assessed by the CAM-ICU instrument.
3 secondary outcomes
Sleep Duration
Time frame: Between enrollment and ICU discharge up to a maximum 10 days in the ICU.
Sleep fragmentation
Time frame: Nightly between enrollment and ICU discharge, up to a maximum of 10 days.
Circadian activity rhythm disruption
Time frame: Daily between enrollment and ICU discharge, up to a maximum of 10 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be shared upon reasonable request from the principal investigator. A data dictionary will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Delirium in the Intensive Care Unit, run by Scripps Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stuti Jaiswal, MD, PhD (858-554-9100, jaiswal.stuti@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Between enrollment and ICU discharge, up to a maximum of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.