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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

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.

Condition or disease Intervention/treatment
Delirium Device: PSG

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MGH Surgery Patients
PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.
Device: PSG
PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.




Primary Outcome Measures :
  1. Association between sleep and POD [ Time Frame: Approximately 5 days ]
    Duration of sleep in delirious vs non-delirious patients


Secondary Outcome Measures :
  1. Serum Profile [ Time Frame: Approximately 24 hours ]
    Levels of inflammatory cytokines and mRNA transcript profiles in delirious vs non-delirious patients



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inpatients over the age of 60 scheduled for a surgical procedure at MGH
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498560


Contacts
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Contact: Oluwaseun Johnson-Akeju, M.D., M.M.Sc. 617-724-7200 oluwaseun.akeju@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.    617-724-7200    ojohnsonakeju@partners.org   
Principal Investigator: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.         
Sponsors and Collaborators
Massachusetts General Hospital

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Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Associate Professor of Anaesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03498560    
Other Study ID Numbers: 2018P000480
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Dyssomnias
Sleep Wake Disorders
Parasomnias
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders