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

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



Sponsors


Source

Massachusetts General Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-06-01

Completion Date

2019-06-01

Primary Completion Date

2019-06-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

Association between sleep and POD
Approximately 5 days

Secondary Outcome

Measure

Time Frame

Serum Profile
Approximately 24 hours

Number Of Groups

1

Enrollment

100

Condition


Intervention

Intervention Type

Device

Intervention Name

 PSG

Description

PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.

Arm Group Label

MGH Surgery Patients


Eligibility

Study Pop

Inpatients over the age of 60 scheduled for a surgical procedure at MGH

Sampling Method

Non-Probability Sample

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

Gender

All

Minimum Age

60 Years

Maximum Age

100 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Contact

Last Name

Oluwaseun Johnson-Akeju, M.D., M.M.Sc.

Phone

617-724-7200

Email



Location

Facility

Massachusetts General Hospital
Boston Massachusetts 02114 United States

Location Countries

Country

United States


Verification Date

2018-04-01

Lastchanged Date

2018-04-12

Firstreceived Date

2018-04-05

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Massachusetts General Hospital

Investigator Full Name

Oluwaseun Johnson-Akeju

Investigator Title

Associate Professor of Anaesthesia


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

MGH Surgery Patients

Description

PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

April 5, 2018

Study First Submitted Qc

April 12, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 12, 2018

Last Update Submitted Qc

April 12, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on April 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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