Actively Recruiting

Age: 70Years +
All Genders
NCT06052397

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Led by Massachusetts General Hospital · Updated on 2026-02-11

150

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3A 70 years old
  • Scheduled to undergo major orthopedic surgery
  • Expected postoperative recovery of more than 24 hours as an inpatient
Not Eligible

You will not qualify if you...

  • Cognitive impairment leading to inability to consent
  • Limited mobility or inability to wear an actigraphy watch
  • Infection at the site of actigraphy watch or allergies to watch materials
  • More than 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
  • Non-English speaking patients

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

L

Lei Gao, MBBS

CONTACT

E

Elizabeth Gleeson, BS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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