N/A
N=38
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Delirium
Bottom Line
View on ClinicalTrials.gov: NCT03498560 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Association Between Sleep and POD — 278.5; 313.5 Minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PSG (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association Between Sleep and POD |
278.5; 313.5 | — |
| SECONDARY Burst Suppression Ratio |
0.11; 0.00 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03498560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.