Impact of Neurochecks on Sleep in Critically Ill Adults

Cerebral Aneurysm Clinical Trial

Official title:

Impact of Neurochecks on Sleep in Critically Ill Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864300
• Other study ID #: UCSD IRB: #806351
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

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