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Clinical Trials/NCT03498560
NCT03498560
Completed
Not Applicable

Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

Massachusetts General Hospital1 site in 1 country38 target enrollmentNovember 1, 2018
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Massachusetts General Hospital
Enrollment
38
Locations
1
Primary Endpoint
Association Between Sleep and POD
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
September 1, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Over 60 years of age
  • Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria

  • Blindness, deafness or the inability to speak English
  • Inability to provide informed consent
  • Objective Drop Criteria
  • Post-operative intubation greater than 24 hours

Outcomes

Primary Outcomes

Association Between Sleep and POD

Time Frame: Night before surgery, approximately 13 hours

Duration of sleep in delirious vs non-delirious patients

Secondary Outcomes

  • Burst Suppression Ratio(Length of surgery (2-12 hours))

Study Sites (1)

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