Earplugs and Eye Masks for Reducing Delirium

NCT ID: NCT03471520

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2018-12-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Earplugs and eye masks

Group Type: EXPERIMENTAL

Earplugs and eye masks

Intervention Type: BEHAVIORAL

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

Interventions

Earplugs and eye masks

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliessa Pavon, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00087770

Identifier Type: -

Identifier Source: org_study_id