Short-term And Longer-term Cognitive Impact Of Neurochecks

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06219889
Status
Recruiting

Conditions

  • Intracerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Frequency of neurochecks — BEHAVIORAL
    the frequency with which a patient is awakened to perform serial examinations

Study Details

The proposed research plan seeks to understand the impact of sleep disruption in the Neurological Intensive Care Unit (ICU) on older patients with acute brain injury (ABI). In current practice, the neurocritical care community performs frequent serial neurological examinations ("neurochecks") in an effort to monitor patients for neurological deterioration following brain injury. Many neurocritical patients are older and/or cognitively fragile, and delirium is common. Although ICU delirium is multifaceted, frequent neurochecks may represent a modifiable risk factor if the investigators can better understand the risks and benefits of various neurocheck frequencies. This project will randomize patients with acute spontaneous intracerebral hemorrhage (ICH) to either hourly (Q1) or every-other-hour (Q2) neurochecks and evaluate the impact of neurocheck frequency on delirium. Second, longer-term cognitive outcomes will be investigated in patients with ICH randomized to Q1 versus Q2 neurochecks with the goal of identifying whether hourly neurochecks increase the risk for dementia.

Key Dates

Start date
Jul 8, 2024
Status verified
Sep 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Active Comparator: Hourly Neurochecks
    Patients will be awakened hourly for their examinations
  • Experimental: Every-Other-Hour Neurochecks
    Patients will be awakened every other hour for their examinations

Primary Outcome Measure

Delirium Duration (short - term cognitive) [ Time Frame: No more than 6 months after date of admission to ICU ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC San Diego HealthSan DiegoCalifornia92103
Jamie N LaBuzetta
619-543-6222

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