Postoperative Delirium: EEG Markers of Sleep and Wakefulness

January 9, 2025 updated by: Ben J.A. Palanca, Washington University School of Medicine

Postoperative delirium is a condition in which patients develop temporary difficulties in maintaining attention and thinking clearly. These new problems can appear after surgery and change throughout the day. This confusion can last several days.

The overall purpose of this study is to measure brain activity during sleep and wakefulness to learn about their relationships to delirium after surgery. While participants may not feel like their normal self during the study, they are in the best position to help us learn how to improve the recovery of brain function and sleep in others having surgery. The investigators need to learn from those who have and have not become confused after their surgical procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Postoperative delirium is a condition that can develop in some older patients after they have surgery and receive general anesthesia. Patients that develop delirium have difficulty maintaining attention and thinking clearly. Both of these issues can come and go throughout the day. The incidence of postoperative delirium is greater than 25% and is associated with longer hospitalization and increased risk of persistent mental and physical decline. It is thought that this disorder may be preventable, but there is no agreed upon way of identifying which patients are at risk for delirium prior to their surgery. Additionally, patients with atypical delirium are often misdiagnosed or undiagnosed postoperatively.

Based on previous research, the researchers have hypothesized that delirium may be directly related to wakefulness and sleep problems, as shown on electroencephalography [EEG]. EEG is a test that records the electrical activity of brain through placement of small wires on a person's scalp. In light of this, the purpose of this study is to evaluate sleep and wakefulness using EEG before, during and after surgery in order to discover any abnormalities of sleep or wakefulness that associate with postoperative delirium onset, severity, and length of recovery. Subjects in this study will have preoperative at home sleep testing performed, using a device called the Sleep Profiler, and questionnaires administered to characterize their mental function and brain function prior to surgery. When they arrive for their scheduled surgery, the subjects will be fitted with the Sleep Profiler to record brain activity during surgery and after surgery for 5 days. Postoperatively, the subjects will be asked to do simple tasks like move toes and fingers and to answer questions that assess their mental state.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential participants recruited from the Barnes Jewish Hospital in St. Louis receiving elective cardiac or major thoracic surgery

Description

Inclusion Criteria:

  1. English speaking
  2. Age 60 or older
  3. Scheduled for cardiac surgery requiring cardiopulmonary bypass for coronary artery bypass grafting and/or heart valve repair/replacement

Exclusion Criteria:

  1. Pre-existing delirium or dementia
  2. Legal blindness or severe deafness
  3. Surgery requiring deep hypothermic circulatory rest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from pre-operative awake EEG measurement to sleep EEG measurement
Time Frame: Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital
Awake EEG recorded at baseline, sleep EEG using Sleep Profiler
Record at baseline visit or, if the subject is an inpatient, once during the day compared to record obtained overnight either at home or in the hospital
Change in baseline diagnosis of delirium to hospital discharge
Time Frame: Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.
Delirium diagnosed using the validated instrument Confusion Assessment Method, Long Form
Diagnosis at baseline, then diagnosis change evaluated 2 times daily post-operatively until hospital discharge or post-operative day 5, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ben Palanca, MD, PhD, Washington University in St Louis SOM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201705018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared with the National Sleep Research Resource within three years after completion of the study. We will register our observational study on clinicaltrials.gov and publish a protocol of our approach and pre-specified analyses by the end of Year 2 of funding.

IPD Sharing Time Frame

Data will be made available within 3 years of study completion and publication and will be available indefinitely.

IPD Sharing Access Criteria

Permission from the principal investigator is required for access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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