Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
1 other identifier
observational
38
1 country
1
Brief Summary
The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
September 4, 2020
CompletedMarch 31, 2022
March 1, 2022
8 months
April 5, 2018
July 9, 2020
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Association Between Sleep and POD
Duration of sleep in delirious vs non-delirious patients
Night before surgery, approximately 13 hours
Secondary Outcomes (1)
Burst Suppression Ratio
Length of surgery (2-12 hours)
Study Arms (1)
MGH Surgery Patients
PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.
Interventions
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Eligibility Criteria
Inpatients over the age of 60 scheduled for a surgical procedure at MGH
You may qualify if:
- Over 60 years of age
- Inpatient and scheduled for surgical procedure at MGH
You may not qualify if:
- Blindness, deafness or the inability to speak English
- Inability to provide informed consent
- Objective Drop Criteria
- Post-operative intubation greater than 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24.
PMID: 33759264DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The quality of many of the PSG recordings was poor and not interpretable. After patients enrolled, many withdrew at the time the PSG was to be placed. So, sleep was recorded for fewer patients. Blood was not analyzed.
Results Point of Contact
- Title
- Dr. Oluwaseun Johnson-Akeju
- Organization
- Massachusetts General Hospital DACCPM
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anaesthesia
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 13, 2018
Study Start
November 1, 2018
Primary Completion
July 1, 2019
Study Completion
September 1, 2019
Last Updated
March 31, 2022
Results First Posted
September 4, 2020
Record last verified: 2022-03