An interventional study of Decreased Neuro Checks overnight in Stroke, Acute, Stroke, Ischemic and Delirium, sponsored by Medical University of South Carolina. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
There have been limited studies on delirium in patients hospitalized with acute stroke. There have been no studies on the potential impact of overnight neuro-checks and resulting sleep disruption on delirium or other outcomes. Additional research is needed to determine if overnight checks are necessary or even harmful. We aim to find out if stopping overnight neuro checks may prevent delirium and benefit the patient.
This study hopes to challenge the clinical paradigm that all patients with acute stroke need around-the-clock neuro-checks. The practice of conducting an NIHSS every 4 hours on patients with acute stroke has never been validated, particularly in clinically stable patients, but is the standard of care. This practice potentially comes at the cost of inducing delirium due to poor sleep which can result in numerous adverse outcomes.
This study hopes to identify the impact of eliminating overnight neuro-checks and prioritize sleep and rest. We hypothesize that increased emphasis on sleep will reduce the incidence of delirium and thereby improve the deleterious effects of delirium such as prolonged length of stay and increased likelihood of being discharged to a facility.
A quality improvement project was undertaken to at MUSC to begin to understand the impact of eliminating overnight neuro-checks. This project was focused on patients on the Inpatient Stroke Service, admitted to 9 East. Starting in October 2022, the Stroke team would identify patients who were medically and neurologically stable and place an order to discontinue overnight neuro-checks. Incidence of delirium, LOS, NIHSS, and mRS were compared using data from 4 months prior (June-September 2022) and 8 months after initiation of the project. Compared to pre-intervention, there was a reduction in patients who were delirious from 34-24% and a reduction in average length of stay by 1.5 days. This preliminary data suggests a positive impact of the intervention. There was no change in NIHSS at discharge or the mRS at discharge suggesting there was no negative impact on the patient's neurologic function by eliminating overnight neuro-checks.
The data collect from this preliminary study is exciting, however, warrants more a more scientific evaluation. The proposed study will be a randomized control trial that will help answer these questions more definitively.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 538 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Exclusion Criteria:
Surgical hemorrhagic stroke Subarachnoid hemorrhage Medical or neurologic instability Pregnancy Inmates
If a patient is randomized to the control group, they will continue to have neuro-checks conducted every 2-4 hours as ordered by the primary team, as per standard of care on the acute stroke service.
If a patient is randomized to the intervention group, the team will discontinue neuro-checks between 8pm and 4am. They will otherwise receive the same care, including overnight vital signs. If the patient has a neurologic or hemodynamic change, the primary team may elect to restart the overnight neuro-checks.
Behavioral: Decreased Neuro Checks overnight
If a patient is randomized to the intervention group, the team will discontinue neuro-checks between 8pm and 4am. They will otherwise receive the same care, including overnight vital signs. If the patient has a neurologic or hemodynamic change, the primary team may elect to restart the overnight neuro-checks.
Incidence of delirium as measured as change in Confusion Assessment Method (CAM)
The Confusion Assessment Method (CAM) is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. The CAM includes four features found to have the greatest ability to distinguish delirium from other types of cognitive impairment. A positive or negative result depends on four criteria: 1. Acute onset and fluctuating course Determined by collateral history or repeated clinic assessment 2. Inattention Counting from 20-1 is a simple (if blunt) test for this 3. Disorganised thinking 4. Altered levels of consciousness The CAM is considered to be positive for the presence of delirium if both features 1 and 2 are present, with at least one of features 3 or 4.The primary outcome will be incidence of delirium as measured as CAM positivity at any point during the hospitalization.
Time frame: From date of randomization until date of hospital discharge, up to 8 weeks
Mean Length of Stay
Average hospitalization (measured in days)
Time frame: From date of hospital admission to date of hospital discharge, up to 8 weeks
Change in National Institutes of Health Stroke Scale (NIHSS) Score
The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairements related to stroke. The impairments are graded on a 3-4 point scale wtih scores that range from 0-42. Patients with a higher score have a more severe impauirment, and patients with a lower score have a less severe impairment.
Time frame: From date of hospital admission to date of hospital discharge. From date of hospital discharge to date of 1month follow up appointment. From date of hospital discharge to date of 3 month follow up appointment.
Modified Rankin Scale
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Time frame: Within 24 hours of hospital admission, within 24 hours of hospital discharge and at 90 day stroke clinic follow up
Discharge Disposition
Location patients are discharged to from the hospital (home vs rehab)
Time frame: On date of hospital discharge , up to 8 weeks from randomization
Plan to share: No
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Medical University of South Carolina