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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06052397
Other study ID # 2023P000596
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date September 2027

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Lei Gao, MBBS
Phone (617)888-2941
Email lgao@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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Study Design


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Length of Hospital Stay Medical Record Review Date of hospital admission up until date of discharge, assessed up to 30 days
Primary Incidence of Delirium Outcome will be assessed using the Confusion Assessment Method (CAM) From postoperative day 1 to postoperative day 3
Secondary Severity of Delirium CAM: Minimum Score=0, Maximum Score=19, Higher Scores: indicate increased severity of delirium From postoperative day 1 to postoperative day 3
Secondary Delirium-free Days CAM Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5
Secondary Postoperative Cognitive Status Telephone Montreal Cognitive Assessment (tMoCA): Minimum Score=0, Maximum Score=22, Higher Scores: indicate better cognitive function Months 1, 3, and 12 after surgery
Secondary Postoperative Health Related Quality of Life - Physical Function PROMIS Physical Function SF 8b V.1.2, with higher scores being considered better While inpatient and months 1, 6, and 12 after surgery
Secondary Postoperative Health Related Quality of Life - Global Health Assessed via the PROMIS Global Health SF V.1.1, with higher scores being considered better While inpatient and months 1, 6, and 12 after surgery
Secondary Postoperative Health Related Quality of Life - Pain Interference Assessed via the PROMIS Pain Interference SF 8a V.1.0, with lower scores being considered better. While inpatient and months 1, 6, and 12 after surgery
Secondary Postoperative Health Related Quality of Life - Cognitive Abilities Assessed via PROMIS Applied Cognition Abilities SF 8a V.1.0 with higher scores being considered better. While inpatient and months 1, 6, and 12 after surgery
Secondary Postoperative Health Related Quality of Life - Sleep Disturbance Assessed via PROMIS Sleep Disturbance SF 4A V.1.0 While inpatient and months 1, 6, and 12 after surgery
Secondary Blood Delirium Biomarkers - IL-6 Blood samples including whole blood and serum will be collected to define the pre and post-operative profiles of IL-6 biomarkers Day of surgery up until postoperative day 3
Secondary Blood Delirium Biomarkers - C-reactive protein Blood samples including whole blood and serum will be collected to define the pre and post-operative profiles of C-reactive protein biomarkers Day of surgery up until postoperative day 3
Secondary Blood Delirium Biomarkers - Tau-PT181 Blood samples including whole blood and serum will be collected to define the pre and post-operative profiles of Tau-PT181 biomarkers Day of surgery up until postoperative day 3
Secondary Blood Delirium Biomarkers - Tau-PT217 Blood samples including whole blood and serum will be collected to define the pre and post-operative profiles of Tau-PT217 biomarkers Day of surgery up until postoperative day 3
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