Delirium in Old AgeNCT04786899
Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
An observational study of Delirium in Old Age and Sleep Disturbance, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium in Old Age, Sleep Disturbance, Circadian Rhythm Sleep Disorder
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hispanic/Latino patients scheduled for cardiothoracic surgery at the University of Miami.
Who may be able to join
- Self identify as Hispanic/Latino or preferred language as Spanish
- Undergoing scheduled elective and urgent cardiothoracic surgery
- 50 years of age and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.
- Medical subject headings
- Parasomnias, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic/Latino patients undergoing cardiothoracic surgery | Observational study of patients scheduled for cardiothoracic surgery as part of standard of care. Patients will be followed up to 30 days prior to surgery and up to 7 days after surgery or hospital discharge, whichever is sooner. Patients preoperative sleep patterns and postoperative delirium will be followed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery
Delirium will be assessed using the Confusion Assessment Method.
Measured: Up to 7 days post surgery.
Secondary outcomes (6)
Percentage of participants with preoperative sleep disturbance
Sleep disturbance as measured by actigraphy data using a wrist-actigraph
Measured: Up to 7 days before surgery
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.
Assess from blood samples.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start12 Feb 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mahanna Gabrielli, University of Miami
- Investigators
- Elizabeth Mahanna Gabrielli, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786899
- Sponsor's protocol ID
- 20200942
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep & Postoperative Delirium in Hispanic/ Latino Patients After Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT04786899
- Acronym / sponsor ID
- 20200942
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study pre-operative sleep problems and delirium in Hispanic/Latino patients after heart and lung surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hispanic/Latino patients undergoing cardiothoracic surgery | – | –Observational study of patients scheduled for cardiothoracic surgery as part of standard of care. Patients will be followed up to 30 days prior to surgery and up to 7 days after surgery or hospital discharge, whichever is sooner. Patients preoperative sleep patterns and postoperative delirium will be followed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic/Latino patients scheduled for cardiothoracic surgery at the University of Miami.
Key inclusion criteria (3 listed)
- Self identify as Hispanic/Latino or preferred language as Spanish
- Undergoing scheduled elective and urgent cardiothoracic surgery
- 50 years of age and older
Key exclusion criteria (7 listed)
- Inability to consent
- preferred language other than English, Spanish or Portuguese
- emergency surgery
- anticipated discharge < 48 hours
- Individuals < 50 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Percentage of participants with preoperative sleep disturbance
Time frame: Up to 7 days before surgery
Pittsburgh Sleep Quality Index (PSQI) score
Time frame: baseline
Insomnia Severity Index (ISI) score
Time frame: baseline
Epsworth Sleepiness scale (ESS) score
Time frame: baseline
STOP-BANG Score
Time frame: baseline
Percentage of patients with risk allele of the melatonin receptor single nucleotide polymorphism.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Mahanna Gabrielli, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in Old Age and Sleep Disturbance, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium in Hispanic/Latino patients after cardiothoracic surgery (time frame: Up to 7 days post surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.