Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headp… (NCT01343095) | Clinical Trial Compass
TerminatedNot Applicable
Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
Stopped: Loss of study staff
United States8 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days Free of Delirium or Coma
Timeframe: During the Study Period (Study Days 0-7 while patients were in ICU)