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
This trial does not accept healthy volunteersQualifiers
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 population
The Targeted/Planned enrollment for the proposed clinical study is consistent with the ethnic and racial composition of Suffolk County, MA. Please see below. American Indian and Alaska Native - 0.7 Native Hawaiian and Other Pacific Islander - 0.2 Asian - 9.3 Black, not Hispanic or Latino - 24.3 White, not Hispanic or Latino - 45.2 Hispanic or Latino - 23.3 Two or more races - 3.7 Female - 51.7
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Sleep and Circadian Rhythms biomarker cohort
Trial outcomes
Primary outcomes
1
Incidence of Delirium
Outcome will be assessed using the Confusion Assessment Method (CAM)
Time frame
From postoperative day 1 to postoperative day 3Secondary outcomes
1
Severity of Delirium
CAM: Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium
Time frame
From postoperative day 1 to postoperative day 32
Delirium-free Days
CAM
Time frame
Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 53
Postoperative Cognitive Status
Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function
Time frame
Months 1, 3, and 12 after surgery4
Postoperative Insomnia Symptom Severity
Insomnia Severity Index, with lower scores being considered better
Time frame
Baseline and months 1, 3, and 12 after surgeryOther outcomes
1
Length of Hospital Stay
Medical Record Review
Time frame
Date of hospital admission up until date of discharge, assessed up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov