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RecruitingNCT04962815Updated Jul 25, 2025

Ceribell Delirium Data Collection Study

An observational study in Delirium, sponsored by Ceribell Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Ceribell Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 5 years later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.

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Conditions studied

  • Delirium

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Keywords

  • delirium
  • EEG
  • Electroencephalogram
03

In context

Delirium

933 studies on the registry are indexed under Delirium; 190 are open to participants now.

This study's planned enrollment of 200 is close to the median of 194 across 342 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Ceribell Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Subjects who experience at least one delirious episode during their ICU stay

Eligibility criteria

Inclusion Criteria: All must be present

  • Age is 18 years or older
  • Admitted to the Intensive Care Unit (ICU)
  • Subject must be fluent in the language in which the delirium assessment is performed

Exclusion Criteria: All must be absent

- Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
6 Days
Patient registry
Yes

Interventions

  • DeviceElectroencephalogram (EEG) Test

    EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.

    Also known as: Delirium Assessments

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What researchers measure

Primary outcomes

  1. Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment

    Research coordinator will perform and collect CAM-ICU assessment data on study subjects

    Time frame: 3 times per day, for a maximum of six (6) days

  2. Perform Electroencephalogram (EEG) Test

    Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients.

    Time frame: 6-8 hours per day, for a maximum of six (6) days

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Study locations

1 of 7 sites recruiting
  • Stanford University
    Stanford, California 94305, United States
    Active, not recruiting

    Not enrolling at this site.

  • Naples Community Hospital
    Naples, Florida 34102, United States
    Active, not recruiting

    Not enrolling at this site.

  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
    Active, not recruiting

    Not enrolling at this site.

  • Mercy
    St Louis, Missouri 63141, United States
    Active, not recruiting

    Not enrolling at this site.

  • Cooper Health
    Camden, New Jersey 08103, United States
    Active, not recruiting

    Not enrolling at this site.

  • UNC Health Rex
    Raleigh, North Carolina 27607, United States
    Active, not recruiting

    Not enrolling at this site.

  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
    • Nicole Ann Toney · Contactnat88@pitt.edu · 412-648-0608
    • Erik Yablonsky · Contactejy3@pitt.edu · 412-648-0608
    • Timothy Girard, MD · Principal investigator
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References and documents

Publications

  • Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753. PubMed 15082703 ↗
  • Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41. doi: 10.1097/TA.0b013e31814b2c4d. PubMed 18580517 ↗
  • McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b. PubMed 23263581 ↗
  • Maldonado JR. Acute Brain Failure: Pathophysiology, Diagnosis, Management, and Sequelae of Delirium. Crit Care Clin. 2017 Jul;33(3):461-519. doi: 10.1016/j.ccc.2017.03.013. PubMed 28601132 ↗
  • Khan BA, Perkins AJ, Gao S, Hui SL, Campbell NL, Farber MO, Chlan LL, Boustani MA. The Confusion Assessment Method for the ICU-7 Delirium Severity Scale: A Novel Delirium Severity Instrument for Use in the ICU. Crit Care Med. 2017 May;45(5):851-857. doi: 10.1097/CCM.0000000000002368. PubMed 28263192 ↗
  • Shenkin SD, Fox C, Godfrey M, Siddiqi N, Goodacre S, Young J, Anand A, Gray A, Hanley J, MacRaild A, Steven J, Black PL, Tieges Z, Boyd J, Stephen J, Weir CJ, MacLullich AMJ. Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method. BMC Med. 2019 Jul 24;17(1):138. doi: 10.1186/s12916-019-1367-9. PubMed 31337404 ↗
  • Maclullich AM, Anand A, Davis DH, Jackson T, Barugh AJ, Hall RJ, Ferguson KJ, Meagher DJ, Cunningham C. New horizons in the pathogenesis, assessment and management of delirium. Age Ageing. 2013 Nov;42(6):667-74. doi: 10.1093/ageing/aft148. Epub 2013 Sep 25. PubMed 24067500 ↗
  • Tieges Z, Evans JJ, Neufeld KJ, MacLullich AMJ. The neuropsychology of delirium: advancing the science of delirium assessment. Int J Geriatr Psychiatry. 2018 Nov;33(11):1501-1511. doi: 10.1002/gps.4711. Epub 2017 Apr 9. PubMed 28393426 ↗
  • Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012. PubMed 11445689 ↗
  • Kaplan PW. The EEG in metabolic encephalopathy and coma. J Clin Neurophysiol. 2004 Sep-Oct;21(5):307-18. PubMed 15592005 ↗

Individual participant data

Plan to share: Yes — Site investigators will have access to the participant EEG data via Ceribell EEG portal. In addition, site investigators will have access to delirium assessments conducted for study purposes.

Supporting information: Study protocol, Informed consent form

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, 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
NCT04962815
Lead sponsor
Ceribell Inc.
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Nov 10, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Jul 25, 2025

Study contacts

Michelle Hofmann, MSN
Contact
michelle.hofmann@ceribell.com
800-436-0826
Jessy Dorn, PhD
Contact
jessy.dorn@ceribell.com
800-436-0826
Jose Maldonado, MD
principal investigator · Stanford University
Timothy Girard, MD
principal investigator · University of Pittsburgh

Oversight

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

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