Status:
RECRUITING
Short-term And Longer-term Cognitive Impact Of Neurochecks
Lead Sponsor:
University of California, San Diego
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 ne...
Detailed Description
Usual care: Patients with ICH are cared for in the NeuroICU by a specialized team including Board-certified neurointensivists, nurse practitioners, and neuro-trained bedside nurses (neuroRNs). These n...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Part 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.
- Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable.
- 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:
- Patients with unstable intracranial bleeding
- Patients with known history of intracranial neurological injury
- Pre-existing cognitive impairment (known or highly suspected based on family-provided history, Activities of Daily Living Questionnaire)
- Pre-existing diagnosed sleep disorder
- Comatose or heavily sedated
- Death expected within 30 days or other terminal illness
- ICH score \>4 (equivalent to mortality risk \>72%)
- Pregnancy
- Incarcerated
- Non-English or non-Spanish speaking
Exclusion
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06219889
Start Date
July 8 2024
End Date
October 31 2029
Last Update
September 10 2025
Active Locations (1)
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1
UC San Diego Health
San Diego, California, United States, 92103