Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06052397

Conditions

Delirium, Postoperative

Cognitive Decline

Dementia

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Delirium, Postoperative

Cognitive Decline

Dementia

Study ID

NCT06052397

Start date

Sep 12, 2023

Status verified date

Feb, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Sleep and Circadian Rhythms biomarker cohort

Cohort will complete a series of blood sample donations (both intraoperatively and postoperatively) as well as complete daily neurocognitive assessments at baseline and on PODs 1 - 3.

Primary outcome measure

  • Incidence of Delirium [ Time Frame: From postoperative day 1 to postoperative day 3 ]

Central Contacts and Locations

Central contacts

Lei Gao, MBBS

(617)888-2941lgao@mgh.harvard.edu

Elizabeth Gleeson, BS

(650)704-6458egleeson1@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lei Gao, MD

6178882941lgao@mgh.harvard.edu

Elizabeth Sugg, BA

6177246700esugg@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-02-11.