Actively Recruiting

Age: 70Years +
All Genders
ID06052397

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Led by Massachusetts General Hospital · Updated on 2026-02-11

150

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating sleep and circadian rhythm biomarkers in older adults undergoing major orthopedic surgery to understand their relationship with postoperative delirium (POD), cognitive decline, and Alzheimer's disease pathology. This prospective observational study aims to define sleep-related biomarkers linked to delirium, explore how Alzheimer's disease-related proteins and inflammation affect delirium risk, and assess genetic influences on these outcomes. Participants will wear an Actiwatch to monitor sleep patterns for up to two weeks before surgery and at 1, 3, and 12 months after surgery. They will donate blood samples preoperatively and postoperatively to analyze protein and genetic markers related to delirium and Alzheimer's disease. Additional data collection includes electrocardiogram (ECG) recordings, cognitive assessments, and questionnaires on sleep quality, mood, pain, and physical and social function. These procedures will occur before surgery, during the hospital stay, and at follow-up periods. Throughout the study, participants will complete baseline and postoperative cognitive evaluations, daily delirium assessments for three days after surgery, and follow-up assessments at 1, 3, and 12 months. Sleep diaries will help track sleep habits alongside Actiwatch data. Clinical information such as surgery details and hospital stay length will be collected from medical records. The study team will maintain contact via phone or email to coordinate virtual visits and support participant involvement over the extended observation period through 2027.

CONDITIONS

Brief Title

Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • Scheduled to undergo major orthopedic surgery
  • Expected postoperative recovery of more than 24 hours as an inpatient
Not Eligible

You will not qualify if you...

  • Cognitive impairment leading to inability to consent
  • Limited mobility or inability to wear an actigraphy watch
  • Infection at the site of actigraphy watch or allergy to watch materials
  • More than 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
  • Non-English speaking patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for consent and baseline assessments including fitting the Actiwatch and cognitive testing

Monitoring

Duration - 7 to 14 days

Participants wear an Actiwatch to monitor sleep and circadian rhythm biomarkers continuously for 7 to 14 days leading up to surgery, and complete sleep diaries during this period. Clinical data and questionnaires about sleep, cognition, mood, pain, and physical/social function are collected.

1 to 2 visits depending on in-person or remote consent; continuous device wear; daily sleep diaries

Surgery and Immediate Post-operative Care

Duration - 4 days

Participants undergo their scheduled major orthopedic surgery with routine clinical care. Blood samples are collected before surgery and on postoperative day 1. Neurocognitive assessments including delirium evaluations and cognitive tests are performed daily on postoperative days 1 through 3. ECG monitoring occurs preoperatively and perioperatively if possible.

Blood draws on day of surgery and postoperative day 1; daily cognitive assessments on postoperative days 1 to 3

Post-operative Follow-up

Duration - 12 months

Participants continue to be assessed for delirium severity and cognitive status up to postoperative day 3. Additional questionnaires and sleep diaries are completed at 1, 3, and 12 months after surgery. Actiwatch monitoring is repeated for one week at each follow-up timepoint, with device mailing and return by participants. Follow-up assessments may be conducted in person, by phone, or remotely.

Three follow-up periods with 1-week Actiwatch wear and questionnaires at months 1, 3, and 12; remote or in-person visits

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

L

Lei Gao, MBBS

E

Elizabeth Gleeson, BS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial.

Armand Mekontso Dessap, Ferran Roche-Campo, Jean-Marie Launay...

https://pubmed.ncbi.nlm.nih.gov/26158245

Postoperative delirium in older adults: best practice statement from the American Geriatrics Society.

American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults

https://pubmed.ncbi.nlm.nih.gov/25535170

Sleep and circadian biomarkers of postoperative delirium (SLEEP-POD): protocol for a prospective and observational cohort study.

Elizabeth Sugg, Elizabeth Gleeson, Sarah N Baker...

https://pubmed.ncbi.nlm.nih.gov/38643014