Earplugs and Eye Masks for Reducing Delirium

• ClinicalTrials.gov Identifier: NCT03471520
• Recruitment Status: Completed
• First Posted: March 20, 2018
• Last Update Posted: November 5, 2021
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

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.

Condition or disease	Intervention/treatment	Phase
Delirium; Hospital Acquired Condition	Behavioral: Earplugs and eye masks	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Earplugs and Eye Masks Worn at Night to Reduce the Incidence of Delirium in General Medicine Inpatients
• Actual Study Start Date: August 6, 2018
• Actual Primary Completion Date: December 8, 2018
• Actual Study Completion Date: December 8, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence of delirium [ Time Frame: The first 5 days of patients' hospitalization ]
   Will be assessed using the CAM
2. Feasibility as measured by number of patients screened [ Time Frame: 5 days ]
3. Feasibility as measured by number of patients ineligible [ Time Frame: 5 days ]
4. Feasibility as measured by number of patients who decline to participate [ Time Frame: 5 days ]
5. Feasibility as measured by number of patients who dropped out of the study [ Time Frame: 5 days ]
6. Feasibility as measured by number of patients who wore the earplugs [ Time Frame: 5 days ]
7. Feasibility as measured by number of patients who wore the eye masks [ Time Frame: 5 days ]
8. Feasibility as measured by number of CAM assessment days [ Time Frame: 5 days ]
9. Feasibility as measured by number of patients who successfully completed the study [ Time Frame: 5 days ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Juliessa Pavon, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03471520
• Other Study ID Numbers: Pro00087770
• First Posted: March 20, 2018
• Last Update Posted: November 5, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Delirium; Iatrogenic Disease; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes