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Completed

NCT Number: NCT03471520

Earplugs and Eye Masks for Reducing Delirium

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.

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Key information

Conditions

Delirium Confusion Disease Attributes Hospital Acquired Condition Iatrogenic Disease Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Earplugs and eye masks

Behavioral

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2018
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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