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

This study has suspended participant recruitment.
(Loss of study staff)
Sponsor:
Information provided by (Responsible Party):
Matthew C. Miles, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01343095
First received: April 13, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Delirium
Sleep Fragmentation
Device: Foam Earplugs
Device: Noise Canceling Headphones
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Days Free of Delirium or coma [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Noise Attenuation [ Time Frame: Overnight (10pm-6am) on study day 2 or 3. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.

  • Amount of sedative use [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]
  • Amount of analgesic use [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Usual Care between 10pm-6am
Active Comparator: Earplugs
Application of 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
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343095

Locations
United States, North Carolina
Wake Forest Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Study Director: Matthew C Miles, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Matthew C. Miles, Assistant Professor, Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01343095     History of Changes
Other Study ID Numbers: IRB00013140
Study First Received: April 13, 2011
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
ICU Delirium
Delirium
Sleep Quality
Sleep Efficiency
ICU Noise
Noise Reduction
Earplugs
Noise Canceling Headphones

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014