An interventional study of Neurocheck frequency in Cerebral Aneurysm, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
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: Thirty patients (N=15 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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 30 is below the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
a. Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
Exclusion Criteria:
Patients awakened for neurological exams every hour
Behavioral: Neurocheck frequency
Patients awakened for neurological exams every-other-hour
Behavioral: Neurocheck frequency
Randomized to hourly or every-other-hour examinations
Sleep efficiency
Ratio of total sleep time compared to time in bed, reported as a percentage
Time frame: Within 24 hours of enrollment
Wakefulness
Blinded quantitative assessment of time spent awake
Time frame: Within 24 hour of enrollment
REM Sleep
Blinded quantitative assessment of time spent in REM sleep
Time frame: Within 24 hour of enrollment
Deep Sleep
Blinded quantitative assessment of time spent in deep sleep
Time frame: Within 24 hour of enrollment
Arousals
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
Time frame: Within 24 hour of enrollment
Sleep quality (subjective)
As measured by Richards Campbell Sleep Questionnaire
Time frame: Within 24 hour of enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Diego