Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery

April 28, 2022 updated by: Elizabeth Mahanna Gabrielli, University of Miami
The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

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
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hispanic/Latino patients scheduled for cardiothoracic surgery at the University of Miami.

Description

Inclusion Criteria:

  1. Self identify as Hispanic/Latino or preferred language as Spanish
  2. Undergoing scheduled elective and urgent cardiothoracic surgery
  3. 50 years of age and older

Exclusion Criteria:

  1. Inability to consent
  2. preferred language other than English, Spanish or Portuguese
  3. emergency surgery
  4. anticipated discharge < 48 hours
  5. Individuals < 50 years of age
  6. Pregnant women
  7. Prisoners

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

Cohorts and Interventions

Group / Cohort
Hispanic/Latino patients undergoing cardiothoracic surgery
Observational study of patients scheduled for cardiothoracic surgery as part of standard of care. Patients will be followed up to 30 days prior to surgery and up to 7 days after surgery or hospital discharge, whichever is sooner. Patients preoperative sleep patterns and postoperative delirium will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery
Time Frame: Up to 7 days post surgery.
Delirium will be assessed using the Confusion Assessment Method.
Up to 7 days post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with preoperative sleep disturbance
Time Frame: Up to 7 days before surgery
Sleep disturbance as measured by actigraphy data using a wrist-actigraph
Up to 7 days before surgery
Pittsburgh Sleep Quality Index (PSQI) score
Time Frame: baseline
Pittsburgh Sleep Quality Index (PSQI) score with overall score ranging from 0-21, where lower scores indicate a higher sleep quality.
baseline
Insomnia Severity Index (ISI) score
Time Frame: baseline
Insomnia Severity Index (ISI) score has a total score ranging from 0 to 28, with higher scores signifying greater insomnia severity.
baseline
Epsworth Sleepiness scale (ESS) score
Time Frame: baseline
Epsworth Sleepiness scale (ESS) score has a total score ranging from 0 to 24, with a higher score indicating greater daytime sleepiness.
baseline
STOP-BANG Score
Time Frame: baseline
STOP-BANG Score has a total score ranging from 0 to 8, with higher scores indicating a higher risk of obstructive sleep apnea.
baseline
Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.
Time Frame: baseline
Assess from blood samples.
baseline

Collaborators and Investigators

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

Sponsor

University of Miami

Investigators

  • Principal Investigator: Elizabeth Mahanna Gabrielli, MD, University of Miami

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)

February 12, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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