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Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

NCT06052397 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-02-11

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lei Gao, MBBS · Massachusetts General Hospital

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052397 on ClinicalTrials.gov