Impact of Neurochecks on Sleep in Critically Ill Adults

NCT05864300 | Active Not Recruiting

• 1 other identifier: UCSD IRB: #806351
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Keywords

neurocheck; sleep; neurological examination

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency

  Ratio of total sleep time compared to time in bed, reported as a percentage

  Within 24 hours of enrollment

Secondary Outcomes (5)

• Wakefulness

  Within 24 hour of enrollment

• REM Sleep

  Within 24 hour of enrollment

• Deep Sleep

  Within 24 hour of enrollment

• Arousals

  Within 24 hour of enrollment

• Sleep quality (subjective)

  Within 24 hour of enrollment

Study Arms (2)

Hourly Neurochecks

ACTIVE COMPARATOR

Patients awakened for neurological exams every hour

Behavioral: Neurocheck frequency

Every-Other-Hour Neurochecks

ACTIVE COMPARATOR

Patients awakened for neurological exams every-other-hour

Behavioral: Neurocheck frequency

Interventions

Neurocheck frequency BEHAVIORAL

Randomized to hourly or every-other-hour examinations

Every-Other-Hour Neurochecks; Hourly Neurochecks

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.

You may not qualify if:

• Patients with past or current intracranial injury or disease.
• Patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries.
• Incomplete resolution of aneurysm.
• Known sleep disorders (e.g., insomnia)
• Pregnancy.
• Incarceration.
• Inability to communicate in English
• Cognitive impairment or lack of decision-making capacity.
• Ongoing sedation.
• Mechanical ventilation

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UC San Diego Health

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Neurosciences

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 18, 2023
• Study Start: August 11, 2023
• Primary Completion: January 6, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2025-03

Locations

US (1)