Sound Modulation for Critical Illness
(SMART Trial)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brian Gehlbach
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The goal of the project is to determine the effects of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the intensive care unit.
Research Team
BK
Brian K Gehlbach, MD
Principal Investigator
Faculty
Eligibility Criteria
This trial is for adults aged 18-99 in critical care expected to stay at least 24 hours. It's not for those with significant hearing loss, drug overdose, substance abuse disorders, untreated sleep disorders, on vasopressors, unresponsive or delirious patients, or those with dementia or neurodegenerative diseases.Exclusion Criteria
I am currently on medication to raise my blood pressure.
I use hearing aids or have significant hearing loss.
I have not been treated for any sleep disorders.
See 5 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants are randomized into control, noise reduction, and noise masking groups to study the effects on heart rate and blood pressure variability
2 days
Continuous monitoring in ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of ICU delirium and length of stay
Up to 28 days
Treatment Details
Interventions
- Sound masking
- Sound reduction
Trial Overview The study tests if sound masking and noise reduction can lower stress in ICU patients. Participants will experience modified sound environments to see if these changes improve their physiological responses related to stress.
Participant Groups
3Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Usual care will be provided.
Group II: Sound maskingActive Control1 Intervention
Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.
Group III: Sound reductionActive Control1 Intervention
Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brian Gehlbach
Lead Sponsor
Trials
2
Recruited
140+
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.