Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
|ClinicalTrials.gov Identifier: NCT01343095|
Recruitment Status : Terminated (Loss of study staff)
First Posted : April 27, 2011
Results First Posted : December 20, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Delirium Sleep Fragmentation||Device: Foam Earplugs Device: Noise Canceling Headphones||Not Applicable|
Delirium is an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. Acute delirium is an increasingly recognized problem in intensive care units (ICUs) in the US and worldwide. ICU Delirium has been estimated to occur in as many as 50 to 80 percent of ICU patients. Delirium in the ICU has been associated with worsened clinical outcomes such as prolonged hospitalization and death [1-4]. Although noise has been shown to negatively influence sleep in the ICU, and sleep disturbance is a recognized contributor to ICU delirium[1-2, 4], there is no well-established link between ICU noise levels and the development of ICU delirium. Optimal strategies for the prevention and treatment of ICU delirium are yet to be defined, and this study will focus on a novel noise-reduction approach which has potential to impact both prevention and treatment [5-8]. Findings will be generalizable to other tertiary care medical intensive care units caring for adult patients.
Objectives Our multidisciplinary team will evaluate the safety and feasibility of direct noise reduction in the Wake Forest University Baptist Medical Center (WFUBMC) Medical Intensive Care Unit (MICU), and any effect on the incidence of ICU delirium.
Methods and Measures Design
- Forty-five (45) patients receiving mechanical ventilation will be randomized to receive either passive direct noise reduction (earplugs), both passive and active direct noise reduction (earplugs and noise-canceling headphones), or no direct noise reduction (usual practice).
- Ambient noise levels and the reduction in noise accomplished by direct noise reduction will be measured according to standardized audiometric techniques.
- Sleep structure, including amount of recovery sleep, will be measured over one night according to standardized polysomnographic (sleep study) techniques
- The incidence of delirium will be assessed as well as multiple other endpoints including but not limited to amount of psychoactive medication prescribed and amount of physical restraints required.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Direct Noise Reduction in the ICU Using Overnight Application of In-ear Earplugs or In-ear Earplugs Plus Noise-Canceling Headphones to Reduce the Incidence and Duration of ICU Delirium|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||June 2015|
No Intervention: Usual Care
Usual Care between 10pm-6am
Active Comparator: Earplugs
Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Device: Foam Earplugs
Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Active Comparator: Earplugs and Headphones
Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
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.
- Days Free of Delirium or Coma [ Time Frame: During the Study Period (Study Days 0-7 while patients were in ICU) ]
- Noise Attenuation [ Time Frame: Overnight (10pm-6am) on study day 2 or 3. ]The reduction in noise experienced by the subject when using the study intervention.
- Sleep Efficiency and Architecture [ Time Frame: Overnight (10pm-6am) on study day 2 or 3 ]Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.
- Amount of Sedative Use (Midazolam and Lorazepam) [ Time Frame: During the Study Period (Study Days 0-7) ]
- Amount of Analgesic Use [ Time Frame: During the Study Period (Study Days 0-7) ]Mean of analgesic daily use
- Amount of Sedative Use (Propofol and Demedetomidine ) [ Time Frame: During the Study Period (Study Days 0-7) ]Mean of sedative daily use (Propofol and Demedetomidine )
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343095
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Study Director:||Matthew C Miles, MD||Wake Forest University Health Sciences|