Digital and Plasma Biomarkers in Delirium | NCT07694206

Studies
Digital and Plasma Biomarkers in Delirium

NCT07694206

Sponsor

Scripps Health

Status

Recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Critical Illness
Delirium in the Intensive Care Unit
Sleep Quality

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2026Actual

Primary Completion Date

Oct 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 2, 2026

First Submission Date that Met QC Criteria

Jul 2, 2026

First Posted Date

Jul 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delirium	Delirium incidence as assessed by the CAM-ICU instrument.	Between enrollment and ICU discharge, up to a maximum of 10 days.

Secondary Outcomes

Measure	Description	Time Frame
Sleep Duration	Daily total sleep duration as measured by actigraphy	Between enrollment and ICU discharge up to a maximum 10 days in the ICU.
Sleep fragmentation	Nightly sleep fragmentation as measured by actigraphy

Other Outcomes

Measure	Description	Time Frame
Delirium duration	As measured by CAM-ICU	between enrollment and ICU discharge up to a maximum of 10 days

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Critically ill older adults.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stuti Jaiswal, MD, PhD	Contact	858-554-9100		jaiswal.stuti@scrippshealth.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Green Hospital	Not yet recruiting	La Jolla	California	92037	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Deidentified participant data will be shared upon reasonable request from the principal investigator. A data dictionary will be provided.

Types

Study Protocol
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020919	Sleep Disorders, Intrinsic

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