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NCT05864300 · ClinicalTrials.gov registry record · NA
Impact of Neurochecks on Sleep in Critically Ill Adults
A NA study of Cerebral Aneurysm, sponsored by University of California, San Diego.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05864300: Active NA study of Cerebral Aneurysm, sponsored by University of California, San Diego.
NCT05864300 is a NA study of Cerebral Aneurysm that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 30 participants, below the 67-participant average among 3 other Cerebral Aneurysm trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864300, a NA study of Cerebral Aneurysm, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 slee
Primary Outcome
Ratio of total sleep time compared to time in bed, reported as a percentage
Conditions Studied
Interventions
- BEHAVIORAL Neurocheck frequency
Study Locations (1)
California
- UC San Diego Health - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-08-11 |
| Est. Completion | 2028-10-01 |
| Phase | NA |
What the registry record for NCT05864300 still lists
NCT05864300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 67-participant average among 3 other Cerebral Aneurysm trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Cerebral Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Neurocheck frequency is the first listed.
NCT05864300 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05864300 about?
NCT05864300 is a clinical study titled "Impact of Neurochecks on Sleep in Critically Ill Adults". 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 betwee...
What is the current status of trial NCT05864300?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-08-11. Estimated completion is 2028-10-01.
What conditions does trial NCT05864300 study?
This clinical trial studies the following conditions: Cerebral Aneurysm.
What interventions are being tested in trial NCT05864300?
The interventions under investigation include: Neurocheck frequency (BEHAVIORAL).
Who is sponsoring clinical trial NCT05864300?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05864300 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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