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Could fewer nighttime checks save brain injury patients from delirium?

NCT ID NCT06219889

Knowledge-focused Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether waking patients with brain bleeding every hour for checks (standard care) versus every two hours affects their confusion and long-term thinking. Researchers will track 120 adults in the ICU for delirium and later cognitive function. The goal is to see if less frequent checks can reduce harm from sleep disruption.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
frequency of neurochecks (behavioral intervention)
What this could lead to
If successful, this could show that reducing how often patients are woken for checks lowers delirium risk and improves long-term thinking after brain injury.
What could go wrong
This is a small, early-stage study (120 participants) looking at a behavioral change, not a drug. Results may not apply to all brain injury patients or change standard care quickly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Part 1): 1. Adult patients (age \>18 years) with spontaneous acute \<45cc in volume with radiographic and clinical stability for ≥6 hours following admission to the ICU. These criteria are based on the literature and experience of the investigative team. 2. Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable. 3. Only first admission to the NeuroICU during the hospitalization will be eligible. Inclusion criteria (Part 2): a. any patient included in part 1 alive at 6 months post-discharge Exclusion Criteria: 1. Patients with unstable intracranial bleeding 2. Patients with known history of intracranial neurological injury 3. Pre-existing cognitive impairment (known or highly suspected based on family-provided history, Activities of Daily Living Questionnaire) 4. Pre-existing diagnosed sleep disorder 5. Comatose or heavily sedated 6. Death expected within 30 days or other terminal illness 7. ICH score \>4 (equivalent to mortality risk \>72%) 8. Pregnancy 9. Incarcerated 10. Non-English or non-Spanish speaking

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Conditions

The condition(s) this trial relates to.

delirium intracerebral hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracerebral hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UC San Diego Health

    RECRUITING

    San Diego, California, 92103, United States

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