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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Earplugs and eye masks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Earplugs and eye masks | Behavioral | Patients in this study will be given earplugs and eye masks to be worn during sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium | Will be assessed using the CAM | The first 5 days of patients' hospitalization |
| Feasibility as measured by number of patients screened | 5 days | |
| Feasibility as measured by number of patients ineligible | 5 days | |
| Feasibility as measured by number of patients who decline to participate | 5 days | |
| Feasibility as measured by number of patients who dropped out of the study | 5 days | |
| Feasibility as measured by number of patients who wore the earplugs | 5 days | |
| Feasibility as measured by number of patients who wore the eye masks | 5 days | |
| Feasibility as measured by number of CAM assessment days | 5 days | |
| Feasibility as measured by number of patients who successfully completed the study | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliessa Pavon, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D007049 | Iatrogenic Disease |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |