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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04786899

Enrollment

Registered

2021-03-08

Start date

2021-02-12

Completion date

2021-12-31

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm Sleep Disorder, Delirium in Old Age, Sleep Disturbance

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.

Countries

United States

Outcome results