Back to resultsEarplugs and Eye Masks for Reducing Delirium
Primary Purpose
Delirium, Hospital Acquired Condition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Earplugs and eye masks
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
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
Sites / Locations
- Duke University Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Earplugs and eye masks
Arm Description
Outcomes
Primary Outcome Measures
Incidence of delirium
Will be assessed using the CAM
Feasibility as measured by number of patients screened
Feasibility as measured by number of patients ineligible
Feasibility as measured by number of patients who decline to participate
Feasibility as measured by number of patients who dropped out of the study
Feasibility as measured by number of patients who wore the earplugs
Feasibility as measured by number of patients who wore the eye masks
Feasibility as measured by number of CAM assessment days
Feasibility as measured by number of patients who successfully completed the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03471520
Brief Title
Earplugs and Eye Masks for Reducing Delirium
Official Title
Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
December 8, 2018 (Actual)
Study Completion Date
December 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Hospital Acquired Condition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Earplugs and eye masks
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Earplugs and eye masks
Intervention Description
Patients in this study will be given earplugs and eye masks to be worn during sleep
Primary Outcome Measure Information:
Title
Incidence of delirium
Description
Will be assessed using the CAM
Time Frame
The first 5 days of patients' hospitalization
Title
Feasibility as measured by number of patients screened
Time Frame
5 days
Title
Feasibility as measured by number of patients ineligible
Time Frame
5 days
Title
Feasibility as measured by number of patients who decline to participate
Time Frame
5 days
Title
Feasibility as measured by number of patients who dropped out of the study
Time Frame
5 days
Title
Feasibility as measured by number of patients who wore the earplugs
Time Frame
5 days
Title
Feasibility as measured by number of patients who wore the eye masks
Time Frame
5 days
Title
Feasibility as measured by number of CAM assessment days
Time Frame
5 days
Title
Feasibility as measured by number of patients who successfully completed the study
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliessa Pavon, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Earplugs and Eye Masks for Reducing Delirium
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