Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
Age >= 70 years old
Scheduled to undergo major orthopedic surgery
Expected postoperative recovery of more than 24 hours as an inpatient
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov