Trial Outcomes & Findings for Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium (NCT NCT03498560)

NCT ID: NCT03498560

Last Updated: 2022-03-31

Results Overview

Duration of sleep in delirious vs non-delirious patients

• Recruitment status: COMPLETED
• Target enrollment: 38 participants
• Primary outcome timeframe: Night before surgery, approximately 13 hours
• Results posted on: 2022-03-31

Participant Flow

Participant milestones

Measure	MGH Surgery Patients PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Overall Study STARTED	38
Overall Study Completed Baseline Assessment	32
Overall Study Completed PSG	25
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	MGH Surgery Patients PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Overall Study Found Ineligible	2
Overall Study Withdrawal by Subject	14
Overall Study Lost to Follow-up	4
Overall Study Death	1

Baseline Characteristics

Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment.

Baseline characteristics by cohort

Measure	MGH Surgery Patients n=38 Participants PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Age, Categorical <=18 years	0 Participants n=38 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=38 Participants
Age, Categorical >=65 years	34 Participants n=38 Participants
Age, Continuous	72 years STANDARD_DEVIATION 5.98 • n=38 Participants
Sex: Female, Male Female	8 Participants n=38 Participants
Sex: Female, Male Male	30 Participants n=38 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment.
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) Asian	1 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) Black or African American	1 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) White	30 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) More than one race	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=32 Participants • Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.
Region of Enrollment United States	38 participants n=38 Participants

PRIMARY outcome

Timeframe: Night before surgery, approximately 13 hours

Population: Many of the PSG data samples that were collected the night of surgery were not interpretable and poor quality.

Duration of sleep in delirious vs non-delirious patients

Outcome measures

Measure	MGH Surgery Patients n=16 Participants PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Association Between Sleep and POD Non Delirium	278.5 Minutes Interval 239.5 to 315.5
Association Between Sleep and POD Delirium	313.5 Minutes Interval 271.3 to 352.5

SECONDARY outcome

Timeframe: Length of surgery (2-12 hours)

Population: Only 14 EEG recordings were analyzed. EEG recordings for other patients were not analyzed due to poor quality or lack of recording due to electronic or manual error during surgery.

Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.

Outcome measures

Measure	MGH Surgery Patients n=14 Participants PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
Burst Suppression Ratio Patients screened positive for delirium	0.11 ratio Interval 0.02 to 0.43
Burst Suppression Ratio Patients screened negative for delirium	0.00 ratio Interval 0.0 to 0.03

Adverse Events

MGH Surgery Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Oluwaseun Johnson-Akeju

Massachusetts General Hospital DACCPM

Phone: 617-724-7200

Email: oluwaseun.akeju@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place