RECRUITING

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Quick Facts

Study Start:2023-09-12
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06052397

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 70 years old
  2. * Scheduled to undergo major orthopedic surgery
  3. * Expected postoperative recovery of more than 24 hours as an inpatient
  1. * Cognitive impairment leading to inability to consent
  2. * Patients with limited mobility or inability to wear an actigraphy watch
  3. * Patients with infection at the site of actigraphy watch, allergies to materials of watch
  4. * Patients with \> two days in the ICU during the month prior to surgery
  5. * Renal or liver failure
  6. * Severe neurocognitive damage or history of psychiatric illness
  7. * Blindness or deafness
  8. * Patients who are non-English speaking

Contacts and Locations

Study Contact

Lei Gao, MBBS
CONTACT
(617)888-2941
lgao@mgh.harvard.edu
Elizabeth Gleeson, BS
CONTACT
(650)704-6458
egleeson1@mgh.harvard.edu

Principal Investigator

Lei Gao, MBBS
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Lei Gao, MBBS, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-12
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-09-12
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Sleep
  • Postoperative Delirium
  • Circadian Rhythms
  • Cognition
  • Dementia

Additional Relevant MeSH Terms

  • Delirium, Postoperative
  • Cognitive Decline
  • Dementia