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NCT Number: NCT05864300

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego Health

San Diego, California, 92130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a. Adult patients 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

Treatment and study plan

Neurocheck frequency

Behavioral

Randomized to hourly or every-other-hour examinations

Primary outcomes

  1. Sleep efficiency

    Time frame: Within 24 hours of enrollment

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

Secondary outcomes

  1. Wakefulness

    Time frame: Within 24 hour of enrollment

    Blinded quantitative assessment of time spent awake

  2. REM Sleep

    Time frame: Within 24 hour of enrollment

    Blinded quantitative assessment of time spent in REM sleep

  3. Deep Sleep

    Time frame: Within 24 hour of enrollment

    Blinded quantitative assessment of time spent in deep sleep

  4. Arousals

    Time frame: Within 24 hour of enrollment

    Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)

  5. Sleep quality (subjective)

    Time frame: Within 24 hour of enrollment

    As measured by Richards Campbell Sleep Questionnaire

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 18, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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