Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this prospective cohort study is to assess potential differences in sleep biomarkers in older adult patients undergoing major orthopedic surgery. The main questions it aims to answer are: 1. To define sleep/circadian biomarkers of delirium (sleep duration, regularity, stability and timing of rhythm) in a prospective observational study. 2. To determine if plasma Alzheimer's disease (AD) pathology/inflammatory burden interacts with or moderates the relationship between a sleep/circadian biomarker and post-operative delirium (POD) risk. 3. To determine whether sleep/circadian regulation interacts with the genetic risk of AD to influence POD/cognitive decline. Participants will be asked to: 1. Donate several blood samples both intraoperatively and postoperatively 2. Complete baseline and postoperative neurocognitive assessments 3. Wear an actigraphy data collection watch for the two weeks prior to their surgery

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Age \>= 70 years old

• Scheduled to undergo major orthopedic surgery

• Expected postoperative recovery of more than 24 hours as an inpatient

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Lei Gao, MBBS
lgao@mgh.harvard.edu
(617)888-2941
Backup
Elizabeth Gleeson, BS
egleeson1@mgh.harvard.edu
(650)704-6458
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2027-09
Participants
Target number of participants: 150
Treatments
Sleep and Circadian Rhythms biomarker cohort
Cohort will complete a series of blood sample donations (both intraoperatively and postoperatively) as well as complete daily neurocognitive assessments at baseline and on PODs 1 - 3.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov