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

Not Applicable

Terminated

Conditions: Delirium
Sleep Fragmentation

Interventions: Device: Foam Earplugs
Device: Noise Canceling Headphones

Registration Number: NCT01343095

Lead Sponsor: Wake Forest University

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Adult patients who are admitted to our MICU for at least 24 hours with at least 72 hours' additional expected stay in ICU, and who are mechanically ventilated

Exclusion Criteria

severe to profound hearing loss
baseline use of hearing aids
eardrum perforation
severe cerumen impaction
head or oromaxillofacial trauma
external ventricular drain or intracranial pressure monitoring devices
comatose patients who are deemed by their attending physician as unlikely to awaken within 72 hours
patient status as comfort-measures only
any other contraindication to the use of earplugs or headphones

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Earplugs and Headphones	Noise Canceling Headphones	Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Earplugs	Foam Earplugs	Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Earplugs and Headphones	Foam Earplugs	Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.

Primary Outcome Measures

Name	Time	Method
Days Free of Delirium or Coma	During the Study Period (Study Days 0-7 while patients were in ICU)

Secondary Outcome Measures

Name	Time	Method
Amount of Sedative Use (Propofol and Demedetomidine )	During the Study Period (Study Days 0-7)	Mean of sedative daily use (Propofol and Demedetomidine )
Noise Attenuation	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	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 Analgesic Use	During the Study Period (Study Days 0-7)	Mean of analgesic daily use
Amount of Sedative Use (Midazolam and Lorazepam)	During the Study Period (Study Days 0-7)