Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
Stopped early · Not applicable
Conditions studied: Delirium, Sleep Fragmentation
In brief
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.
Key facts
- Study ID
- NCT01343095
- Run by
- Wake Forest University
- People needed
- 8
- Starts
- 2011-05-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2018-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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