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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sound techniques can reduce stress in seriously ill patients in intensive care. It compares usual care with two sound-based approaches: sound masking with relaxing music through headphones and sound reduction with noise-canceling ear muffs. The researchers aim to determine if these methods positively affect stress-related health measures. Potential participants include those in an adult critical care unit for at least 24 hours, without untreated sleep disorders or significant hearing issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance stress management in critical care settings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that sound masking and sound reduction are safe for critically ill patients?

Research has shown that sound masking, such as listening to relaxing music, can positively impact critical care settings. Studies have found that music helps patients sleep better and feel less stressed, without significant side effects. Music is generally well-received and can enhance sleep and mental well-being in seriously ill patients.

For noise reduction, studies indicate that noise-cancelling headphones significantly lower the noise patients hear. This creates a quieter environment, potentially making the intensive care experience more pleasant. These headphones have been used safely and can help reduce stress and possibly pain.

Both sound masking and noise reduction methods are safe and well-tolerated, making them promising options for managing stress and improving comfort in seriously ill patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sound modulation techniques being studied for critical illness because they offer a non-invasive way to potentially improve patient comfort and recovery. Unlike traditional treatments that might focus on medication or physical interventions, sound masking uses headphones and relaxing music, which can create a soothing auditory environment. Meanwhile, sound reduction employs noise-canceling headphones to significantly decrease ambient noise, which could help reduce stress and improve sleep quality for patients in noisy hospital settings. These methods are promising because they may enhance patient well-being without the side effects associated with pharmaceuticals.

What evidence suggests that sound masking and sound reduction could be effective for critically ill patients?

This trial will compare different sound modulation techniques for critically ill patients. Studies have shown that sound masking, such as listening to relaxing music, can improve sleep and reduce stress in very sick patients. In this trial, one group of participants will receive sound masking with headphones and relaxing music. Research indicates that music chosen by either a therapist or the patient can also lower anxiety in ICU patients. Another group will use noise reduction headphones, which have been found to decrease noise levels and improve patient comfort, even if the noise remains slightly louder than ideal. Both methods—using music to mask sound and employing noise reduction tools—show promise in helping patients feel calmer and more comfortable in the ICU. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8112442/

Use of music to enhance sleep and psychological outcomes in ... We will assess whether music listening improves sleep and psychological outcomes in critically ill patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1036731424002996

A systematic review of the comparative effects of sound ... Overall, both music selected by researcher/music therapist or patient are found effective in alleviating psychological outcomes in ICU patients. Ames et al ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03019133

Study Details | NCT03019133 | Trial to Evaluate the Effects ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9295531/

Decreasing delirium through music listening (DDM) in ... Our study is a two-arm, randomized parallel-group, clinical trial to evaluate the efficacy of music intervention compared to a silence-track attention control ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/counter/pdf/10.1186/s13054-015-0855-3.pdf?utm_source=consensus

Effects of earplugs and eye masks combined with relaxing ... Our aim in this study was to evaluate the effects of using earplugs and eye masks, combined with listening to music, on sleep and hormone secretion in ICU ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984824/

The Effect of Noise-Masking Earbuds (SleepBuds) on ... We tested whether use of noise-masking earbuds can improve reported sleep quality, sleepiness, and stress level in health care shift workers.

7. regenstrief.org regenstrief.org/article/slow-tempo-relaxing-music-to-address-delirium/

Slow-tempo relaxing music to address delirium in ill older ... Refines practice: Findings counter the assumption that early, slow-tempo playlists via headphones will improve delirium/coma-free days in the ICU. Advances ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000175

Impact and efficacy of Sound Machine on Sleep in ... White- noise and other similar masking noises seem to improve sleep efficiency in hospitalized adults, with good tolerability. Only limited ...