Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06052397
Status
Recruiting
Apply to this trial

Conditions

  • Cognitive Decline
  • Delirium, Postoperative
  • Dementia

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Sep 12, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence of Delirium [ Time Frame: From postoperative day 1 to postoperative day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Lei Gao, MD
[email protected]
6178882941
Elizabeth Sugg, BA
[email protected]
6177246700

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By research site
Massachusetts General Hospital· Boston, MA

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