Clinical trial NCT05864300: Impact of Neurochecks on Sleep in Critically Ill Adults
Official title: Impact of Neurochecks on Sleep in Critically Ill Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: neurocheck; sleep; neurological examination
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep efficiency
timeFrame: Within 24 hours of enrollment
Secondary outcomes:
measure: Wakefulness
timeFrame: Within 24 hour of enrollment
measure: REM Sleep
timeFrame: Within 24 hour of enrollment
measure: Deep Sleep
timeFrame: Within 24 hour of enrollment
measure: Arousals
timeFrame: Within 24 hour of enrollment
measure: Sleep quality (subjective)
timeFrame: Within 24 hour of enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health
state: California
Study officials:
References: