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Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498560
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Tracking Information
First Submitted Date April 5, 2018
First Posted Date April 13, 2018
Last Update Posted Date August 5, 2019
Actual Study Start Date November 1, 2018
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
Association between sleep and POD [ Time Frame: Approximately 5 days ]
Duration of sleep in delirious vs non-delirious patients
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
Serum Profile [ Time Frame: Approximately 24 hours ]
Levels of inflammatory cytokines and mRNA transcript profiles in delirious vs non-delirious patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Official Title Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Brief Summary The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.
Detailed Description During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients over the age of 60 scheduled for a surgical procedure at MGH
Condition Delirium
Intervention Device: PSG
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Study Groups/Cohorts MGH Surgery Patients
PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.
Intervention: Device: PSG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 1, 2019)
25
Original Estimated Enrollment
 (submitted: April 12, 2018)
100
Estimated Study Completion Date June 1, 2020
Actual Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Over 60 years of age
  • Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria:

  • Blindness, deafness or the inability to speak English
  • Inability to provide informed consent

Objective Drop Criteria

  • Post-operative intubation greater than 24 hours
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Oluwaseun Johnson-Akeju, M.D., M.M.Sc. 617-724-7200 oluwaseun.akeju@mgh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03498560
Other Study ID Numbers 2018P000480
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date August 2019