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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: Completed NA study, sponsored by Duke University.
NCT03471520 is a NA study that has completed, run by Duke University. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed using the CAM
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 |
What the finished NCT03471520 record still lists
NCT03471520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Earplugs and eye masks is the first listed.
NCT03471520 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03471520's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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