Neurocheck Frequency for Brain Aneurysm Patients' Sleep Quality

Overseen By Jamie N LaBuzetta

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Intracranial injury, Sleep disorders, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Neurocheck Frequency for improving sleep quality in brain aneurysm patients?

The study on 'Dynamic Detection of Delayed Cerebral Ischemia' suggests that frequent monitoring, like hourly checks, can help in early detection of complications, which might indirectly support better management and potentially improve sleep quality by reducing anxiety and ensuring timely intervention. ^{1 2 3 4 5}

Is Neurocheck Frequency safe for humans?

The research articles provided do not contain specific safety data for Neurocheck Frequency or similar treatments in humans. ^{6 7 8 9 10}

How does the Neurocheck Frequency treatment for brain aneurysm patients' sleep quality differ from other treatments?

The Neurocheck Frequency treatment is unique because it focuses on optimizing the frequency of neurological exams to improve sleep quality in brain aneurysm patients. Unlike traditional approaches that involve frequent neurochecks, which can disrupt sleep and potentially worsen neurological outcomes, this treatment aims to balance necessary monitoring with the need for restorative sleep. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for adults over 18 who've had a successful elective coiling procedure for an unruptured brain aneurysm and are in the ICU. It's not for those with past brain injuries, sleep disorders, cognitive issues, ongoing sedation, mechanical ventilation, pregnancy, or communication barriers in English.

Exclusion Criteria

I am currently on medication to keep me sedated.

You are currently using a machine to help you breathe.

My aneurysm has not fully healed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Initial Monitoring

Patients are monitored every 15-30 minutes for up to 6 hours post-procedure

6 hours

Continuous monitoring

Randomized Neurochecks

Patients undergo Q1 or Q2 neurochecks with EEG monitoring for at least 8 hours overnight

24 hours

Continuous monitoring

Follow-up

Participants are monitored for sleep characteristics and complete the Richards-Campbell Sleep Questionnaire

1 day

1 visit (in-person)

Treatment Details

Interventions

• Neurocheck frequency

Trial Overview The study tests if checking patients' neurological status hourly versus every other hour after brain surgery affects their sleep quality. Participants will be monitored using EEG during overnight hours to assess different stages of sleep and complete a questionnaire on sleep quality.

Participant Groups

Group I: Hourly Neurochecks Active Control 1 Intervention

Patients awakened for neurological exams every hour

Group II: Every-Other-Hour Neurochecks Active Control 1 Intervention

Patients awakened for neurological exams every-other-hour

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A new hourly risk score for detecting delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage was developed using vital signs and demographic data from 310 patients, achieving a classification accuracy of 0.83.

This risk score was able to predict DCI events in external datasets with 64% and 91% accuracy, potentially allowing for earlier clinical intervention and reducing neurological injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Detection of Delayed Cerebral Ischemia: A Study in 3 Centers. Megjhani, M., Terilli, K., Weiss, M., et al.[2022]

In a study of 169 patients with subarachnoid hemorrhage (SAH) from the Takashima Stroke Registry, the 28-day case-fatality rate was significantly higher on weekdays (51.7%) compared to weekends (32.6%).

The increased fatality rate on weekdays persisted even after adjusting for various factors such as age, sex, and medical history, indicating a potential circaseptan variation in SAH outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circaseptan variation in case-fatality rate for patients with acute subarachnoid hemorrhage (Takashima Stroke Registry 1988-2003). Turin, TC., Kita, Y., Rumana, N., et al.[2010]

The study of 251 patients with aneurysmal subarachnoid hemorrhage (aSAH) over 5 years revealed a significant shift in treatment practices, with a move from coil embolization to clip ligation for securing aneurysms, indicating a change in clinical management strategies.

Post-discharge follow-up for aSAH survivors improved, leading to better recognition and treatment of complications like delayed hydrocephalus, and highlighted the need for multidisciplinary clinics to address cognitive deficits in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Aneurysmal Subarachnoid Hemorrhage: Variation in Clinical Practice and Unmet Need for Follow-up among Survivors-A Single-Center Perspective. Delpirou Nouh, C., Samkutty, DG., Chandrashekhar, S., et al.[2020]

In a study of 41 patients recovering from subarachnoid hemorrhage, momentary fatigue was found to significantly increase throughout the day, highlighting the need for tailored management strategies.

The research identified three distinct subgroups of patients based on their daily fatigue patterns, with the largest group experiencing a consistent increase in fatigue, suggesting that personalized approaches to treatment could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily patterns of fatigue after subarachnoid haemorrhage: an ecological momentary assessment study. De Vries, EA., Heijenbrok-Kal, MH., Van Kooten, F., et al.[2023]

In a study of 89 patients who survived subarachnoid hemorrhage (SAH), 34% reported severe sleep problems, which included difficulties with initiating and maintaining sleep, and excessive daytime sleepiness.

Patients with severe sleep disorders experienced significantly reduced quality of life, and detailed sleep studies in a subset revealed high rates of sleep fragmentation and other sleep disorders, indicating a strong link between sleep issues and overall well-being post-SAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disorders of sleep and wake in patients after subarachnoid hemorrhage. Schuiling, WJ., Rinkel, GJ., Walchenbach, R., et al.[2022]

In a study of 384 subjects, quantitative neurological tests for arm tremor, postural sway, and vibrotactile sensitivity were found to be effective predictors of clinical outcomes, suggesting they could be more sensitive than traditional clinical examinations.

The toe vibrotactile sensitivity test was the most predictive, with a 63% probability of abnormal clinical results in the worst-performing quartile, indicating its potential utility in epidemiological studies as a substitute for physical exams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between clinical examination and quantitative tests of neurologic function among 384 subjects. Steenland, K., Dick, R., Fine, L.[2019]

Computer-administered testing systems have been developed to assess the effects of neurotoxicant exposure in the workplace, showing sensitivity and reliability in various study settings, including acute and chronic exposure assessments.

There is a need for better-developed testing methods for clinical evaluations, as current neurobehavioral surveillance programs in industry are essential for establishing baseline data and reference points for individuals at risk of neurotoxic exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational screening for neurotoxicity: computerized techniques. Letz, R.[2019]

Current methods for assessing neurotoxicity risk are inadequate, as highlighted by various reports, and there is a need for more biologically based, quantitative procedures that incorporate continuous data and biomarkers.

The symposium discussed enhancing neurotoxicant risk assessments by using benchmark dose approaches and physiologically based pharmacokinetic data, which could lead to more accurate evaluations compared to traditional safety factor methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologically based, quantitative risk assessment of neurotoxicants. Slikker, W., Crump, KS., Andersen, ME., et al.[2018]

A survey of 34 developmental neurotoxicity studies from 16 laboratories revealed significant variability in the quality and adequacy of positive control data, which is crucial for assessing neurodevelopmental effects.

Only 3 out of the 16 laboratories provided sufficient positive control data for all major endpoints, highlighting the need for improved standards in neurotoxicity testing to ensure reliable and interpretable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative retrospective analysis of positive control data in developmental neurotoxicity studies. Crofton, KM., Makris, SL., Sette, WF., et al.[2009]

High doses of compounds can lead to neurotoxicity, which is often first detected through behavioral changes in animals during toxicity testing.

Neurological examinations and additional tests, such as measuring nerve conduction velocity and assessing behavior in controlled environments, are essential for characterizing neurotoxic effects and determining safe dosage levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comments on the assessment of neurotoxicity in routine toxicity studies. Schaeppi, U.[2013]

A survey of 177 healthcare providers revealed that both ordering and performing providers preferred every-other-hour neurochecks for patients with acute brain injury, rather than hourly checks, indicating a consensus on reducing frequency for better patient care.

Ordering providers expressed concerns that hourly neurochecks could be detrimental to patients, while performing providers felt guidelines should be more prescriptive, highlighting a significant difference in attitudes towards the frequency and necessity of these assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocheck Frequency: Determining Perceptions and Barriers to Implementation of Evidence-Based Practice. LaBuzetta, JN., Kazer, MR., Kamdar, BB., et al.[2023]

Frequent neurological examinations, or 'neurochecks', are essential for monitoring patients after acute brain injury, but they may inadvertently cause additional harm by disrupting sleep.

There is a significant gap in research regarding the patterns of neurological decline and the long-term effects of these frequent assessments, highlighting the need for better evaluation and optimization of neurocheck practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reassessing hourly neurochecks. LaBuzetta, JN., Kamdar, BB., Malhotra, A.[2023]

Prolonged intensive neurological assessments in neurocritical care can lead to significant sleep deprivation, which negatively affects patients' true neurological status and overall recovery.

The authors argue for a paradigm shift in care, suggesting that allowing adequate sleep for patients after the initial 36-48 hours post-intracranial events is crucial for improving recovery outcomes and should be prioritized alongside other assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fundamental Need for Sleep in Neurocritical Care Units: Time for a Paradigm Shift. Kishore, K., Cusimano, MD.[2021]

In a pilot study of 20 patients in the neurointensive care unit, 95% experienced neurological deterioration, with most events occurring within the first 24 hours, highlighting the high prevalence of such deterioration in this setting.

Despite frequent hourly neurological checks, 75% of patients developed delirium, suggesting that while these checks are important for acute monitoring, they may also contribute to sleep deprivation and worsen patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Deprivation in Neurointensive Care Unit Patients From Serial Neurological Checks: How Much Is Too Much? McLaughlin, DC., Hartjes, TM., Freeman, WD.[2018]

In a study of 124 TBI patients in the ICU, 71.8% underwent hourly neurological assessments for an average of 2.82 days, but prolonged assessments (over 4 days) were linked to a significantly longer hospital stay (23 days vs. 9 days).

While hourly checks are crucial in the acute phase for monitoring serious conditions, reducing the duration of these assessments for patients unlikely to need surgery may prevent unnecessary sleep deprivation and improve overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hourly neurologic assessments for traumatic brain injury in the ICU. Stone, JJ., Childs, S., Smith, LE., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dynamic Detection of Delayed Cerebral Ischemia: A Study in 3 Centers. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Circaseptan variation in case-fatality rate for patients with acute subarachnoid hemorrhage (Takashima Stroke Registry 1988-2003). [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Management of Aneurysmal Subarachnoid Hemorrhage: Variation in Clinical Practice and Unmet Need for Follow-up among Survivors-A Single-Center Perspective. [2020]

4. Sweden pubmed.ncbi.nlm.nih.gov

Daily patterns of fatigue after subarachnoid haemorrhage: an ecological momentary assessment study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Disorders of sleep and wake in patients after subarachnoid hemorrhage. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Agreement between clinical examination and quantitative tests of neurologic function among 384 subjects. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Occupational screening for neurotoxicity: computerized techniques. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Biologically based, quantitative risk assessment of neurotoxicants. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A qualitative retrospective analysis of positive control data in developmental neurotoxicity studies. [2009]

10. Germany pubmed.ncbi.nlm.nih.gov

Comments on the assessment of neurotoxicity in routine toxicity studies. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Neurocheck Frequency: Determining Perceptions and Barriers to Implementation of Evidence-Based Practice. [2023]

12. Scotland pubmed.ncbi.nlm.nih.gov

Reassessing hourly neurochecks. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Fundamental Need for Sleep in Neurocritical Care Units: Time for a Paradigm Shift. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Sleep Deprivation in Neurointensive Care Unit Patients From Serial Neurological Checks: How Much Is Too Much? [2018]

15. England pubmed.ncbi.nlm.nih.gov

Hourly neurologic assessments for traumatic brain injury in the ICU. [2015]