Impact of Neurochecks on Sleep in Critically Ill Adults

NCT ID: NCT05864300

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-11
• Study Completion Date: 2028-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hourly Neurochecks

Patients awakened for neurological exams every hour

Group Type: ACTIVE_COMPARATOR

Neurocheck frequency

Intervention Type: BEHAVIORAL

Randomized to hourly or every-other-hour examinations

Every-Other-Hour Neurochecks

Patients awakened for neurological exams every-other-hour

Group Type: ACTIVE_COMPARATOR

Neurocheck frequency

Intervention Type: BEHAVIORAL

Randomized to hourly or every-other-hour examinations

Interventions

Neurocheck frequency

Randomized to hourly or every-other-hour examinations

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jamie Labuzetta

Clinical Professor of Neurosciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UC San Diego Health

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jamie N LaBuzetta

Role: CONTACT

jlabuzetta@ucsd.edu

619-543-6222

Facility Contacts

Jamie N LaBuzetta

Role: primary

jlabuzetta@ucsd.edu

619-543-6222

Other Identifiers

UCSD IRB: #806351

Identifier Type: -

Identifier Source: org_study_id