search
Back to results

Impact of Neurochecks on Sleep in Critically Ill Adults

Primary Purpose

Cerebral Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurocheck frequency
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Aneurysm focused on measuring neurocheck; sleep; neurological examination

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: a. Adult patients age >18 years who are status post uncomplicated elective coiling of unruptured cerebral aneurysm. Exclusion Criteria: 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

Sites / Locations

  • UC San Diego HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hourly Neurochecks

Every-Other-Hour Neurochecks

Arm Description

Patients awakened for neurological exams every hour

Patients awakened for neurological exams every-other-hour

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wakefulness
Blinded quantitative assessment of time spent awake
REM Sleep
Blinded quantitative assessment of time spent in REM sleep
Deep Sleep
Blinded quantitative assessment of time spent in deep sleep
Arousals
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
Sleep quality (subjective)
As measured by Richards Campbell Sleep Questionnaire

Full Information

First Posted
May 1, 2023
Last Updated
August 11, 2023
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT05864300
Brief Title
Impact of Neurochecks on Sleep in Critically Ill Adults
Official Title
Impact of Neurochecks on Sleep in Critically Ill Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Twenty-two patients (N=11 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
Keywords
neurocheck; sleep; neurological examination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hourly Neurochecks
Arm Type
Active Comparator
Arm Description
Patients awakened for neurological exams every hour
Arm Title
Every-Other-Hour Neurochecks
Arm Type
Active Comparator
Arm Description
Patients awakened for neurological exams every-other-hour
Intervention Type
Behavioral
Intervention Name(s)
Neurocheck frequency
Intervention Description
Randomized to hourly or every-other-hour examinations
Primary Outcome Measure Information:
Title
Sleep efficiency
Description
Ratio of total sleep time compared to time in bed, reported as a percentage
Time Frame
Within 24 hours of enrollment
Secondary Outcome Measure Information:
Title
Wakefulness
Description
Blinded quantitative assessment of time spent awake
Time Frame
Within 24 hour of enrollment
Title
REM Sleep
Description
Blinded quantitative assessment of time spent in REM sleep
Time Frame
Within 24 hour of enrollment
Title
Deep Sleep
Description
Blinded quantitative assessment of time spent in deep sleep
Time Frame
Within 24 hour of enrollment
Title
Arousals
Description
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
Time Frame
Within 24 hour of enrollment
Title
Sleep quality (subjective)
Description
As measured by Richards Campbell Sleep Questionnaire
Time Frame
Within 24 hour of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a. Adult patients age >18 years who are status post uncomplicated elective coiling of unruptured cerebral aneurysm. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie N LaBuzetta
Phone
619-543-6222
Email
jlabuzetta@ucsd.edu
Facility Information:
Facility Name
UC San Diego Health
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie N LaBuzetta
Phone
619-543-6222
Email
jlabuzetta@ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Impact of Neurochecks on Sleep in Critically Ill Adults

We'll reach out to this number within 24 hrs