Cerebral AneurysmNCT05864300
Impact of Neurochecks on Sleep in Critically Ill Adults
A study testing Neurocheck frequency in people with Cerebral Aneurysm, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Neurocheck frequency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
Who cannot join
- 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.
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- Inability to communicate in English
- Cognitive impairment or lack of decision-making capacity.
- Ongoing sedation.
- Mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Neurocheck frequency
- Keywords
- neurocheck; sleep; neurological examination
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocheck frequencyBehavioural
Randomized to hourly or every-other-hour examinations
| Study group | Role | What they receive |
|---|---|---|
| Hourly Neurochecks | Active comparator | Patients awakened for neurological exams every hour Receives: Behavioral: Neurocheck frequency |
| Every-Other-Hour Neurochecks | Active comparator | Patients awakened for neurological exams every-other-hour Receives: Behavioral: Neurocheck frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Ratio of total sleep time compared to time in bed, reported as a percentage
Measured: Within 24 hours of enrollment
Secondary outcomes (5)
Wakefulness
Blinded quantitative assessment of time spent awake
Measured: Within 24 hour of enrollment
REM Sleep
Blinded quantitative assessment of time spent in REM sleep
Measured: Within 24 hour of enrollment
Deep Sleep
Blinded quantitative assessment of time spent in deep sleep
Measured: Within 24 hour of enrollment
Arousals
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
Measured: Within 24 hour of enrollment
Sleep quality (subjective)
As measured by Richards Campbell Sleep Questionnaire
Measured: Within 24 hour of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start11 Aug 2023
- Primary completion6 Jan 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jamie Labuzetta, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864300
- Sponsor's protocol ID
- UCSD IRB: #806351
- Status last verified
- Apr 2026
- First submitted
- 1 May 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neurochecks on Sleep in Critically Ill Adults
- ClinicalTrials.gov ID
- NCT05864300
- Acronym / sponsor ID
- UCSD IRB: #806351
- Conditions
- Cerebral Aneurysm
- Keywords
- neurocheck; sleep; neurological examination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hourly Neurochecks | Active comparator | Behavioral: Neurocheck frequencyPatients awakened for neurological exams every hour |
| Every-Other-Hour Neurochecks | Active comparator | Behavioral: Neurocheck frequencyPatients awakened for neurological exams every-other-hour |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocheck frequencyRandomized to hourly or every-other-hour examinations | Behavioural | Every-Other-Hour Neurochecks, Hourly Neurochecks |
Primary outcome
Sleep efficiency
Time frame: Within 24 hours of enrollment
Ratio of total sleep time compared to time in bed, reported as a percentage
5 secondary outcomes
Wakefulness
Time frame: Within 24 hour of enrollment
REM Sleep
Time frame: Within 24 hour of enrollment
Deep Sleep
Time frame: Within 24 hour of enrollment
Arousals
Time frame: Within 24 hour of enrollment
Sleep quality (subjective)
Time frame: Within 24 hour of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocheck frequency in people with Cerebral Aneurysm, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Within 24 hours of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.