Status:

RECRUITING

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Delirium, Postoperative

Cognitive Decline

Eligibility:

All Genders

70+ years

Brief 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: ...

Detailed Description

This study is a prospective, observational study designed to identify changes in protein biomarkers levels as a function of delirium incidence and delirium severity scores based on Confusion Assessmen...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 12 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06052397

Start Date

September 12 2023

End Date

September 1 2027

Last Update

November 12 2024

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114