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

NCT01343095 | Terminated Results FDA Device

• 1 other identifier: IRB00013140
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Sleep Fragmentation

Keywords

ICU Delirium; Delirium; Sleep Quality; Sleep Efficiency; ICU Noise; Noise Reduction; Earplugs; Noise Canceling Headphones

Outcome Measures

Primary Outcomes (1)

• Days Free of Delirium or Coma

  During the Study Period (Study Days 0-7 while patients were in ICU)

Secondary Outcomes (5)

• Noise Attenuation

  Overnight (10pm-6am) on study day 2 or 3.

• Sleep Efficiency and Architecture

  Overnight (10pm-6am) on study day 2 or 3

• Amount of Sedative Use (Midazolam and Lorazepam)

  During the Study Period (Study Days 0-7)

• Amount of Analgesic Use

  During the Study Period (Study Days 0-7)

• Amount of Sedative Use (Propofol and Demedetomidine )

  During the Study Period (Study Days 0-7)

Study Arms (3)

Usual Care

NO INTERVENTION

Usual Care between 10pm-6am

Earplugs

ACTIVE COMPARATOR

Application of foam earplugs from 10pm-6am nightly for seven nights or until ICU discharge.

Device: Foam Earplugs

Earplugs and Headphones

ACTIVE COMPARATOR

Foam Earplugs and Noise canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.

Device: Foam Earplugs; Device: Noise Canceling Headphones

Interventions

Foam Earplugs DEVICE

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

Earplugs; Earplugs and Headphones

Noise Canceling Headphones DEVICE

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

Earplugs and Headphones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Delirium; Sleep Deprivation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders; Sleep Disorders, Intrinsic

Results Point of Contact

• Title: Matthew C. Miles
• Organization: Wake Forest Baptist Health

mmiles@wakehealth.edu

336-716-7765

Study Officials

• Matthew C Miles, MD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 27, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 12, 2018
• Results First Posted: December 20, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)