Sound Modulation for Critical Illness

(SMART Trial)

Overseen By Brian Gehlbach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brian Gehlbach

Disqualifiers: Substance abuse, Sleep disorders, Hearing loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

120 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Brian K Gehlbach, MD

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 Intervention

Usual care will be provided.

Group II: Sound masking Active Control 1 Intervention

Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.

Group III: Sound reduction Active Control 1 Intervention

Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.

Who Is Running the Clinical Trial?

Brian Gehlbach

Lead Sponsor

Trials

2

Recruited

140+