RecruitingNCT06052397

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium


Sponsor

Massachusetts General Hospital

Enrollment

150 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 70 Years

Inclusion Criteria3

  • Age >= 70 years old
  • Scheduled to undergo major orthopedic surgery
  • Expected postoperative recovery of more than 24 hours as an inpatient

Exclusion Criteria8

  • Cognitive impairment leading to inability to consent
  • Patients with limited mobility or inability to wear an actigraphy watch
  • Patients with infection at the site of actigraphy watch, allergies to materials of watch
  • Patients with > two days in the ICU during the month prior to surgery
  • Renal or liver failure
  • Severe neurocognitive damage or history of psychiatric illness
  • Blindness or deafness
  • Patients who are non-English speaking

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06052397


Related Trials