Earplugs and Eye Masks for Reducing Delirium

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

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 Overview

• Status: Completed
• Conditions: Delirium; Hospital Acquired Condition
• Intervention / Treatment: Behavioral: Earplugs and eye masks

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
• Age >= 65

Exclusion Criteria:

• Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
• Admitted as "observation" (i.e., expected length of stay < 2 nights)
• Admitted > 24 hours prior to time of enrollment
• Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
• Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
• Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available
• Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure
• Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)
• Delirium present at time of enrollment
• Glasgow Coma Scale (GCS) < 10 at time of enrollment
• Enrolled in this trial during a previous admission (i.e., we will not resample)
• Enrolled in a separate trial this admission
• Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)
• Significant fall risk per nursing assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Earplugs and eye masks	Behavioral: Earplugs and eye masks; Patients in this study will be given earplugs and eye masks to be worn during sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Juliessa Pavon, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): December 8, 2018
• Study Completion (Actual): December 8, 2018

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Iatrogenic Disease
• Other Study ID Numbers: Pro00087770

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No