NCT03471520

Earplugs and Eye Masks for Reducing Delirium

Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Delirium
• Hospital Acquired Condition

Interventions

Type	Name	Description
BEHAVIORAL	Earplugs and eye masks	Patients in this study will be given earplugs and eye masks to be worn during sleep

Timeline

• Start date: 2018-08-06
• Primary completion: 2018-12-08
• Completion: 2018-12-08
• First posted: 2018-03-20
• Last updated: 2021-11-05

Locations

1 site across 1 country: United States