NCT06052397 Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
| NCT ID | NCT06052397 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Delirium, Postoperative |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-09-12 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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
Inclusion Criteria: * Age \>= 70 years old * Scheduled to undergo major orthopedic surgery * Expected postoperative recovery of more than 24 hours as an inpatient Exclusion Criteria: * 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
Contact & Investigator
Lei Gao, MBBS
STUDY CHAIR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06052397 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Delirium, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052397 currently recruiting?
Yes, NCT06052397 is actively recruiting participants. Contact the research team at lchoe@bwh.harvard.edu for enrollment information.
Where is the NCT06052397 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06052397 clinical trial?
NCT06052397 is sponsored by Massachusetts General Hospital. The principal investigator is Lei Gao, MBBS at Massachusetts General Hospital. The trial plans to enroll 150 participants.