← Back to Search

Sound Modulation for Critical Illness (SMART Trial)

N/A

Waitlist Available

Led By Brian K Gehlbach, MD

Research Sponsored by Brian Gehlbach

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours

Be older than 18 years old

Must not have

Use of vasopressors

Use of hearing aids, or known significant conductive or sensory hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well two different types of noise-reduction help ICU patients manage stress-related physiological parameters.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve sound modulation rather than medication or invasive procedures, side effects are minimal but may include discomfort due to changes in usual noise levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 99 years old and will be in intensive care for at least a day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on medication to raise my blood pressure.

Select...

I use hearing aids or have significant hearing loss.

Select...

I have not been treated for any sleep disorders.

Select...

I am on a ventilator through a tube in my windpipe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at the time of icu discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at the time of icu discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at the time of icu discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment for reporting.