MedTrace Logo

Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones

NCT01343095 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-09-12

Study results available
· View outcomes & findings →

Summary

This study seeks to examine the effects of overnight noise reduction in critically ill patients who are receiving mechanical ventilation. The investigators will randomly place subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs and noise-canceling headphones. The investigators will monitor for safety, and will measure the amount of delirium experienced by subjects, record the amount of sedating and painkilling medicines required, and measure sleep quality during the study, among other information. The investigators will also measure noise levels experienced by patients in each group. The investigators predict that the use of overnight noise reduction will be safe and will reduce the amount of delirium by improving the quality of sleep in critically ill patients.

Conditions

  • Delirium
  • Sleep Fragmentation

Interventions

DEVICE

Foam Earplugs

Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)

DEVICE

Noise Canceling Headphones

Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Matthew C Miles, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-12-31
Completion
2015-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343095 on ClinicalTrials.gov