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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.
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. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGH Surgery Patients | PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSG | Device | PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Sleep and POD | Duration of sleep in delirious vs non-delirious patients | Night before surgery, approximately 13 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Burst Suppression Ratio | Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression. | Length of surgery (2-12 hours) |
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Inclusion Criteria:
Exclusion Criteria:
Objective Drop Criteria
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Inpatients over the age of 60 scheduled for a surgical procedure at MGH
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33759264 | Derived | Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
38 Patients enrolled in the study. 32 Patients completed the baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Based on number of patients who enrolled. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Association Between Sleep and POD | Duration of sleep in delirious vs non-delirious patients | Many of the PSG data samples that were collected the night of surgery were not interpretable and poor quality. | Posted | Median | Inter-Quartile Range | Minutes | Night before surgery, approximately 13 hours |
|
|
Adverse event data was collected form the time the patient was enrolled to the completion of the follow-up assessment at 30 days.
This study is an observational study, not an interventional study. Thus, all adverse events patients encounter during this time period would not be related to the research study.
Adverse events and other events were determined by regular chart review.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The quality of many of the PSG recordings was poor and not interpretable. After patients enrolled, many withdrew at the time the PSG was to be placed. So, sleep was recorded for fewer patients. Blood was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oluwaseun Johnson-Akeju | Massachusetts General Hospital DACCPM | 617-724-7200 | oluwaseun.akeju@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2018 | Jul 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2019 | Jul 9, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Death |
|
| Count of Participants |
| Participants |
|
| Age, Continuous | Based on number of patients who enrolled. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Based on number of patients who enrolled. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Based on number of patients who completed the baseline assessment. | Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Based on number of patients who completed the baseline assessment. | Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Burst Suppression Ratio | Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression. | 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. | Posted | Median | Inter-Quartile Range | ratio | Length of surgery (2-12 hours) |
|
|
|
| 1 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|