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NCT03471520 · ClinicalTrials.gov registry record · NA
Earplugs and Eye Masks for Reducing Delirium
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03471520 is a NA study that has completed, run by Duke University. The registered enrollment target is 12 participants.
The verdict
NCT03471520, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL Earplugs and eye masks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-08-06 |
| Est. Completion | 2018-12-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03471520
The ClinicalTrials.gov registry entry for NCT03471520 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Earplugs and eye masks is the first listed.
NCT03471520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03471520 about?
NCT03471520 is a clinical study titled "Earplugs and Eye Masks for Reducing Delirium". 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 pil...
What is the current status of trial NCT03471520?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2018-08-06. Estimated completion is 2018-12-08.
What interventions are being tested in trial NCT03471520?
The interventions under investigation include: Earplugs and eye masks (BEHAVIORAL).
Who is sponsoring clinical trial NCT03471520?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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