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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05864300
Other study ID # UCSD IRB: #806351
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2023
Est. completion date October 1, 2028

Study information

Verified date March 2024
Source University of California, San Diego
Contact Jamie N LaBuzetta
Phone 619-543-6222
Email jlabuzetta@ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 1, 2028
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: a. Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm. Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Neurocheck frequency
Randomized to hourly or every-other-hour examinations

Locations

Country Name City State
United States UC San Diego Health San Diego California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep efficiency Ratio of total sleep time compared to time in bed, reported as a percentage Within 24 hours of enrollment
Secondary Wakefulness Blinded quantitative assessment of time spent awake Within 24 hour of enrollment
Secondary REM Sleep Blinded quantitative assessment of time spent in REM sleep Within 24 hour of enrollment
Secondary Deep Sleep Blinded quantitative assessment of time spent in deep sleep Within 24 hour of enrollment
Secondary Arousals Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine) Within 24 hour of enrollment
Secondary Sleep quality (subjective) As measured by Richards Campbell Sleep Questionnaire Within 24 hour of enrollment
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