Clinical Trials Directory

Trials / Completed

CompletedNCT03498560

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

Status
Completed
Phase
Study type
Observational
Enrollment
38 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
60 Years – 100 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEPSGPSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Timeline

Start date
2018-11-01
Primary completion
2019-07-01
Completion
2019-09-01
First posted
2018-04-13
Last updated
2022-03-31
Results posted
2020-09-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03498560. Inclusion in this directory is not an endorsement.