Summary

Eligibility
for people ages 25-75 (full criteria)
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Jamie Labuzetta
Headshot of Jamie Labuzetta
Jamie Labuzetta

Description

Summary

Background: Following acute brain injury (ABI), patients are monitored in the intensive care unit (ICU) where providers rely on frequent neurological examinations ("neurochecks") to assess for neurodeterioration. Serial neurochecks are part of guideline recommendations, but there is equipoise between hourly (Q1) and every-other-hour (Q2) evaluation. In the ICU, care-related awakenings occur frequently, but it is unclear if differential neurocheck frequencies result in differential sleep, providing the scientific premise for this proposal.

Population: Twenty-two patients (N=11 per group) who have undergone elective aneurysm coiling will be enrolled. On post-operative day (POD) 0, patients will be screened and approached for informed consent if they do not meet exclusion criteria, e.g., prior intracranial injury, sleep disorders, cognitive impairment, mechanical ventilation. Patients with elective aneurysm coiling are being chosen because they require ICU level of care following their intracranial procedure, but do not have structural brain injury or ongoing sedation needs that might impact sleep measurements.

Methods: Usual care: Patients are monitored every 15-30 minutes for up to 6 hours post-procedure, then Q1 or Q2 for up to 24 hours. If these patients remain stable, they are discharged home on post-operative day (POD) 1. Proposed Intervention: Enrolled patients will be randomized to Q1 or Q2 neurochecks following the institutionally required 6 hours of stable neurological and vascular checks. Once randomized, patients will undergo placement of electroencephalogram (EEG) with video, electrooculogram, and chin lead. The video EEG will be in place for at least 8 hours to include the overnight (10PM-6AM) time period. Following completion of the recording, the signals obtained will be reviewed by a blinded polysomnographic sleep technician for sleep characteristics including quantitative assessments of wakefulness, deep (N3) sleep, REM sleep, sleep efficiency, and sleep fragmentation and arousals. On POD1, patients and their nurse will fill out the Richards-Campbell Sleep Questionnaire to rate subjective sleep quality.

Keywords

Cerebral Aneurysm, neurocheck; sleep; neurological examination, Intracranial Aneurysm, Aneurysm, Neurocheck frequency, Hourly Neurochecks, Every-Other-Hour Neurochecks

Eligibility

You can join if…

Open to people ages 25-75

  1. Adult patients age >18 years who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.

You CAN'T join if...

  1. Patients with past or current intracranial injury or disease.
  2. Patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries.
  3. Incomplete resolution of aneurysm.
  4. Known sleep disorders (e.g., insomnia)
  5. Pregnancy.
  6. Incarceration.
  7. Inability to communicate in English
  8. Cognitive impairment or lack of decision-making capacity.
  9. Ongoing sedation.

    10. Mechanical ventilation

Location

  • UC San Diego Health accepting new patients
    San Diego California 92130 United States

Lead Scientist at UCSD

  • Jamie Labuzetta
    Dr. LaBuzetta is an internationally trained clinician researcher. She completed her medical training at UC San Diego, and did post-graduate research at both Oxford and Cambridge Universities in England. After completing her neurology residency training at MGH and Brigham in Boston (Harvard Hospitals), she returned to UC San Diego for Neurocritical Care fellowship.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05864300
Study Type
Interventional
Participants
Expecting 22 study participants
Last Updated