Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 18, 2023
Trial Information
Current as of October 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how sleep patterns and biological markers related to sleep might affect older adults who are recovering from major orthopedic surgery. The researchers want to find out if certain sleep characteristics—like how long and how regularly patients sleep—can help predict the risk of experiencing delirium, which is a sudden change in mental status that can happen after surgery. They are also examining whether factors like inflammation or genetic risk for Alzheimer's disease might influence this relationship.
To participate in the study, you need to be at least 70 years old and scheduled for major orthopedic surgery, with an expected recovery time of more than 24 hours in the hospital. Participants will be asked to wear a special watch that tracks sleep for two weeks before surgery, provide blood samples during and after the operation, and complete some cognitive tests before and after surgery. The study is currently looking for volunteers who meet these criteria, and it’s important to note that individuals with certain medical conditions or cognitive impairments may not be eligible to participate.
Gender
ALL
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
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Patients applied
Trial Officials
Lei Gao, MBBS
Principal Investigator
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported