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

Completed

• Conditions: Delirium
• Interventions: Device: PSG

• Registration Number: NCT03498560
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2018-11-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-09-01
• Results First Submitted: 2020-07-09
• Results First Submitted QC: 2020-09-02
• Results First Posted: 2020-09-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MGH Surgery Patients	PSG	PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.

Primary Outcome Measures

Name	Time	Method
Association Between Sleep and POD	Night before surgery, approximately 13 hours	Duration of sleep in delirious vs non-delirious patients

Secondary Outcome Measures

Name	Time	Method
Burst Suppression Ratio	Length of surgery (2-12 hours)	Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States