UC San Diego Health
San Diego, California, 92130, United States
NCT Number: NCT05864300
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
San Diego, California, 92130, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
Exclusion criteria
Randomized to hourly or every-other-hour examinations
Time frame: Within 24 hours of enrollment
Ratio of total sleep time compared to time in bed, reported as a percentage
Time frame: Within 24 hour of enrollment
Blinded quantitative assessment of time spent awake
Time frame: Within 24 hour of enrollment
Blinded quantitative assessment of time spent in REM sleep
Time frame: Within 24 hour of enrollment
Blinded quantitative assessment of time spent in deep sleep
Time frame: Within 24 hour of enrollment
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
Time frame: Within 24 hour of enrollment
As measured by Richards Campbell Sleep Questionnaire
University of California, San Diego
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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