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Neurocheck Frequency for Brain Aneurysm Patients' Sleep Quality

N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients age >18 years who are status post uncomplicated elective coiling of unruptured cerebral aneurysm.
Be older than 18 years old
Must not have
Ongoing sedation
Incomplete resolution of aneurysm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hour of enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates if different frequencies of neurochecks in the ICU result in different levels of sleep in patients who have had elective aneurysm coiling. 22 patients will have EEGs monitored overnight to measure their sleep quality.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
There may not be direct side effects from the intervention as it involves monitoring frequency rather than medication; however, changes in neurocheck frequency could potentially affect patient restfulness and overall recovery experience.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and had a successful elective procedure for an unruptured brain aneurysm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication to keep me sedated.
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My aneurysm has not fully healed.
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I have a diagnosed sleep disorder.
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I cannot communicate in English.
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I have difficulty making decisions due to cognitive issues.
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I have had a brain injury or disease in the past or currently.
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I have a known blockage in my neck or brain arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hour of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hour of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep efficiency
Secondary study objectives
Arousals
Deep Sleep
REM Sleep
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Hourly NeurochecksActive Control1 Intervention
Patients awakened for neurological exams every hour
Group II: Every-Other-Hour NeurochecksActive Control1 Intervention
Patients awakened for neurological exams every-other-hour

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,189 Previous Clinical Trials
1,587,678 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,195,241 Total Patients Enrolled

Media Library

Hourly Neurochecks Clinical Trial Eligibility Overview. Trial Name: NCT05864300 — N/A
Brain Aneurysm Research Study Groups: Hourly Neurochecks, Every-Other-Hour Neurochecks
Brain Aneurysm Clinical Trial 2023: Hourly Neurochecks Highlights & Side Effects. Trial Name: NCT05864300 — N/A
Hourly Neurochecks 2023 Treatment Timeline for Medical Study. Trial Name: NCT05864300 — N/A
~20 spots leftby Oct 2027