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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786899
• Other study ID #: 20200942
• Status: Completed
• Start date: February 12, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder
• Delirium
• Delirium in Old Age
• Dyssomnias
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Disturbance
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery	Delirium will be assessed using the Confusion Assessment Method.	Up to 7 days post surgery.
Secondary	Percentage of participants with preoperative sleep disturbance	Sleep disturbance as measured by actigraphy data using a wrist-actigraph	Up to 7 days before surgery
Secondary	Pittsburgh Sleep Quality Index (PSQI) score	Pittsburgh Sleep Quality Index (PSQI) score with overall score ranging from 0-21, where lower scores indicate a higher sleep quality.	baseline
Secondary	Insomnia Severity Index (ISI) score	Insomnia Severity Index (ISI) score has a total score ranging from 0 to 28, with higher scores signifying greater insomnia severity.	baseline
Secondary	Epsworth Sleepiness scale (ESS) score	Epsworth Sleepiness scale (ESS) score has a total score ranging from 0 to 24, with a higher score indicating greater daytime sleepiness.	baseline
Secondary	STOP-BANG Score	STOP-BANG Score has a total score ranging from 0 to 8, with higher scores indicating a higher risk of obstructive sleep apnea.	baseline
Secondary	Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.	Assess from blood samples.	baseline