Sleep Disturbance Clinical Trial
Official title:
Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
Verified date | April 2022 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
United States,
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 |
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