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

Completed

• Conditions: Delirium in Old Age; Sleep Disturbance; Circadian Rhythm Sleep Disorder

• Registration Number: NCT04786899
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-12
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States