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OpenTrials
Completed

NCT Number: NCT04786899

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

The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.

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Key information

Conditions

Delirium in Old Age Chronobiology Disorders Circadian Rhythm Sleep Disorder Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Parasomnias Sleep Disorders, Circadian Rhythm Sleep Disturbance Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Inability to consent
  • preferred language other than English, Spanish or Portuguese
  • emergency surgery
  • anticipated discharge < 48 hours
  • Individuals < 50 years of age
  • Pregnant women
  • Prisoners

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.

    Time frame: baseline

    Assess from blood samples.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2021
Registry last updated
Apr 29, 2022

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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