Earplugs and Eye Masks for Reducing Delirium

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471520
• Other study ID #: Pro00087770
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: December 8, 2018

Study information

• Verified date: October 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 8, 2018
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hospital Acquired Condition
• Iatrogenic Disease

Intervention

Behavioral:
• Earplugs and eye masks
Patients in this study will be given earplugs and eye masks to be worn during sleep

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium	Will be assessed using the CAM	The first 5 days of patients' hospitalization
Primary	Feasibility as measured by number of patients screened		5 days
Primary	Feasibility as measured by number of patients ineligible		5 days
Primary	Feasibility as measured by number of patients who decline to participate		5 days
Primary	Feasibility as measured by number of patients who dropped out of the study		5 days
Primary	Feasibility as measured by number of patients who wore the earplugs		5 days
Primary	Feasibility as measured by number of patients who wore the eye masks		5 days
Primary	Feasibility as measured by number of CAM assessment days		5 days
Primary	Feasibility as measured by number of patients who successfully completed the study		5 days