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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498560
• Other study ID #: 2018P000480
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Dyssomnias
• Parasomnias

Intervention

Device:
• PSG
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association Between Sleep and POD	Duration of sleep in delirious vs non-delirious patients	Night before surgery, approximately 13 hours
Secondary	Burst Suppression Ratio	Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.	Length of surgery (2-12 hours)