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 — BEHAVIORALthe 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 NeurochecksPatients will be awakened hourly for their examinations
- Experimental: Every-Other-Hour NeurochecksPatients 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
- Jamie N LaBuzetta18582491331
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego Health | San Diego | California | 92103 |
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