Assessing sleep and circadian rhythms in older adults after major orthopedic surgery
Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
This study is testing how sleep patterns and certain biological markers in older adults after major orthopedic surgery can help us understand the risk of confusion and memory problems afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06052397 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify sleep and circadian biomarkers associated with postoperative delirium in older adults undergoing major orthopedic surgery. Participants will wear an actigraphy watch to monitor their sleep patterns and provide blood samples for analysis of Alzheimer's disease pathology and inflammation. The study will also evaluate how these biomarkers relate to cognitive decline and the risk of delirium post-surgery. Follow-up assessments will occur remotely at 1, 3, and 12 months after surgery to gather additional data on cognitive function and sleep.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 70 and above scheduled for major orthopedic surgery with an expected inpatient recovery of more than 24 hours.
Not a fit: Patients with significant cognitive impairment, severe neurocognitive damage, or those unable to wear an actigraphy watch will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention strategies for postoperative delirium in older adults.
How similar studies have performed: While studies have explored sleep and delirium, this specific approach focusing on sleep biomarkers in the context of major orthopedic surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Lei Gao, MBBS — Massachusetts General Hospital
- Study coordinator: Lei Gao, MBBS
- Email: lgao@mgh.harvard.edu
- Phone: (617)888-2941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.