There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
12
Patients in this study will be given earplugs and eye masks to be worn during sleep
Duke University Health System
Durham, North Carolina, United States
Incidence of delirium
Will be assessed using the CAM
Time frame: The first 5 days of patients' hospitalization
Feasibility as measured by number of patients screened
Time frame: 5 days
Feasibility as measured by number of patients ineligible
Time frame: 5 days
Feasibility as measured by number of patients who decline to participate
Time frame: 5 days
Feasibility as measured by number of patients who dropped out of the study
Time frame: 5 days
Feasibility as measured by number of patients who wore the earplugs
Time frame: 5 days
Feasibility as measured by number of patients who wore the eye masks
Time frame: 5 days
Feasibility as measured by number of CAM assessment days
Time frame: 5 days
Feasibility as measured by number of patients who successfully completed the study
Time frame: 5 days
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