Earplugs and Eye Masks for Reducing Delirium

NCT03471520 | Completed

• 1 other identifier: Pro00087770
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Earplugs and eye masks

EXPERIMENTAL

Behavioral: Earplugs and eye masks

Interventions

Earplugs and eye masks BEHAVIORAL

Patients in this study will be given earplugs and eye masks to be worn during sleep

Earplugs and eye masks

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Delirium; Iatrogenic Disease

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Juliessa Pavon, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 20, 2018
• Study Start: August 6, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

US (1)