Impact of Neurochecks on Sleep in Critically Ill Adults
Key facts
- Who runs it
- University of California, San Diego
- Where
- San Diego, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 30 people, planned
- Started
- 11 Aug 2023
- Ended
- 1 Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Neurocheck frequency
- Record updated
- 4 September 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm
Who cannot take part
- Patients with past or current intracranial injury or disease
- Known sleep disorders (e.g., insomnia)
- Cognitive impairment or lack of decision-making capacity
- Patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries
- Incomplete resolution of aneurysm
- Pregnancy
- Incarceration
- Inability to communicate in English
- Ongoing sedation
- Mechanical ventilation
Where in United States
- UC San Diego HealthSan Diego, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Hourly NeurochecksExisting treatment, for comparison
Patients awakened for neurological exams every hour
Treatment: Neurocheck frequency
- Every-Other-Hour NeurochecksExisting treatment, for comparison
Patients awakened for neurological exams every-other-hour
Treatment: Neurocheck frequency
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 September 2026