NOICE Device for Pain

Overseen By Thomas Caruso, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Chronotropic, Pain medications

Disqualifiers: Hearing loss

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

Compensation: Varies

Number of Visits: 2

Duration: 15 minutes per session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new technology using sound, called the NOICE device, can help people manage heat pain more effectively. The study will test how well spatial audio (a type of 3D sound experience) can distract from pain. Participants will either start with the sound or without it and then switch halfway through. This trial suits English-speaking adults with normal hearing who do not have ongoing medical conditions affecting safe participation and are not using certain heart or pain medications. As an unphased trial, this study offers participants the chance to contribute to innovative research and potentially benefit from cutting-edge technology.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any pain medications to participate in this trial.

What prior data suggests that the NOICE device is safe for use in this study?

Research has shown that noise-cancelling devices might help reduce pain. In one study, noise-cancelling earmuffs lessened the intensity of moderate-to-severe pain. Another study found that noise-reducing earphones could lower the need for pain medication after surgery. These results suggest that the NOICE device, which uses special sound technology, might also help with pain. However, the NOICE device is not a medical device and is being tested to see if it can help people manage heat pain better.

Specific information about any side effects or safety concerns with the NOICE device is not available. Since this trial involves a non-medical device, it might pose less risk. This suggests the device could be easy to use without problems. However, joining any study should involve considering the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional pain management treatments that often rely on medications or invasive procedures, the NOICE device uses spatial audio stimulation to potentially alleviate pain. This non-invasive approach is unique because it targets the brain's perception of pain through sound, offering an alternative to pharmacological solutions like opioids, which can have significant side effects and addiction risks. Researchers are excited about the NOICE device as it promises a safer and more innovative way to manage pain without the drawbacks of conventional therapies.

What evidence suggests that the NOICE device is effective for pain?

Research shows that spatial audio technology can enhance sound and emotional experiences, potentially aiding in pain management. Studies have found that new virtual reality (VR) technology, when combined with sound, effectively reduces pain during medical procedures. Both virtual reality and music therapy consistently ease pain. Additionally, research has shown that combining sound with methods like electrical body stimulation may help treat chronic pain. These findings suggest that the NOICE device, which uses spatial audio, could improve heat pain management. In this trial, participants will experience different treatment arms: one with spatial audio stimulation and another without, to evaluate the device's effectiveness in managing pain. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in how spatial audio affects heat pain threshold. Specific eligibility criteria are not provided, but typically participants should be free from conditions that could interfere with the study.

Inclusion Criteria

I speak English.

My hearing is normal.

Exclusion Criteria

I am taking pain medication.

I am experiencing hearing loss.

I am taking medication that affects my heart rate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a crossover study to evaluate the impact of spatial audio on heat pain threshold using the NOICE device

15 minutes per session

2 sessions (in-person)

Follow-up

Participants are monitored for device satisfaction, anxiety levels, and system usability immediately after each intervention

immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• NOICE device

Trial Overview

The NOICE device's effectiveness on pain and anxiety is being tested. Participants will try the device with and without distraction to see if it changes their heat pain threshold. The study design allows each person to experience both scenarios.

How Is the Trial Designed?

Group I: Spatial audio stimulation Experimental Treatment 2 Interventions

Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study.

Group II: No spatial audio stimulation Experimental Treatment 2 Interventions

Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

A systematic review of adverse event (AE) reporting in clinical trials of intravenous and invasive pain treatments revealed no significant improvement in reporting quality since the 2004 CONSORT guidelines, with only 5 out of 10 reporting standards met on average.

Overall, 8% of the articles reviewed did not report any AE information, highlighting a critical need for better transparency and adherence to reporting standards in clinical trials to fully understand the risks associated with pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. Williams, MR., McKeown, A., Pressman, Z., et al.[2018]

A systematic review of nonpharmacologic pain treatment trials revealed significant inadequacies in adverse event (AE) reporting, with less than half of the trials detailing specific AE assessment methods.

AE reporting was more comprehensive in trials involving patients compared to those with healthy volunteers, indicating a need for improved adherence to reporting guidelines across all types of trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. Hunsinger, M., Smith, SM., Rothstein, D., et al.[2018]

In a study of Medicare beneficiaries averaging 80 years old, opioids were found to have a significantly higher risk of cardiovascular events and all-cause mortality compared to nonselective NSAIDs (nsNSAIDs).

Coxibs showed a reduced risk of gastrointestinal bleeding compared to nsNSAIDs, but both coxibs and nsNSAIDs had similar fracture risks, while opioids were associated with a much higher fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative safety of analgesics in older adults with arthritis. Solomon, DH., Rassen, JA., Glynn, RJ., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12511085/

Exploring pain and suffering through spatial acousmatic music

Spatialization and sound movement are integral aspects of acousmatic music, enhancing sensory experiences and deepening emotional engagement (31) ...

2.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03266-6

Efficacy of virtual reality for pain relief in medical procedures

Trials conducted over the last 10 years evaluated newer VR technology with sound immersive augmentation (13/47, 26%) [101,102,103,104,105,106, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7279616/

Virtual reality, music, and pain: developing the premise for ...

Virtual reality (VR) and music therapy (MT) have been separately explored as interventions for alleviating pain with relatively consistent levels of success.

4.

twin-cities.umn.edu

twin-cities.umn.edu/news-events/study-finds-sound-plus-electrical-body-stimulation-has-potential-treat-chronic-pain

Study finds that sound plus electrical body stimulation has ...

Study finds that sound plus electrical body stimulation has potential to treat chronic pain. August 11, 2022. Person being treated by sound and ...

5.

spj.science.org

spj.science.org/doi/10.34133/cbsystems.0160

Sensors and Devices Guided by Artificial Intelligence for ...

We summarize the basics of pain pathology and introduce various sensors and devices for pain monitoring, assessment, and relief.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12523209/

Effect of noise isolation with noise-cancelling earmuffs ...

Intraoperative noise isolation using noise-cancelling earmuffs reduces the incidence of moderate-to-severe pain and reduces pain severity ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06918470

Research on the Effect of Noise Cancelling Headphones ...

By using noise reduction earphones during surgery, the patient's postoperative pain score and demand for opioids are observed, providing a basis and reference ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0163834324000562

Effects of postoperative environmental noise on surgery ...

We found that higher-level postoperative noise correlated with more severe postoperative pain in patients undergoing cesarean delivery.

9.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf13/p130022b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Risks associated with the use of a SCS system: lead migration; IPG migration; allergic response or tissue reaction to the implanted system material; hematoma or.