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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the NOICE device treatment for pain?

The NOICE device may be similar to the Nociception Level (NOL) index, which has been explored for assessing pain in various settings, such as postoperative care and chronic pain management. Studies have shown that multi-parameter technologies like the NOL index can help evaluate pain by monitoring physiological changes, suggesting potential effectiveness in pain assessment and management. ^{1 2 3 4 5}

Is the NOICE Device generally safe for humans?

The available research highlights that adverse event (AE) reporting in nonpharmacologic pain treatments, like the NOICE Device, is often inadequate, meaning safety data might be incomplete or inconsistent. However, trials involving patients tend to report more detailed AE information than those with healthy volunteers. ^{6 7 8 9 10}

How is the NOICE device treatment different from other pain treatments?

The NOICE device is unique because it likely uses a combination of mechanical stimulation, such as vibration, to reduce pain, which is different from traditional pain treatments that often rely on medications. This approach can provide pain relief without the side effects associated with drugs. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. This research is not studying the NOICE device specifically and the device is not a medical device.

Eligibility Criteria

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

My hearing is normal.

I speak English.

Exclusion Criteria

I am taking pain medication.

I am experiencing hearing loss.

I am taking medication that affects my heart rate.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Nociception level index variations in patients with complex regional pain syndrome: a pilot study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented SF-36. [2004]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Analgesia Nociception Index Monitoring in the Evaluation of Postoperative Pain in Children: A Prospective Observational Pilot Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Acute pain therapy in postanesthesia care unit directed by skin conductance: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Adverse Events and Nocebo Effects in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The comparative safety of analgesics in older adults with arthritis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Quantitative pinch stimulator for exploring evoked nociceptive responses: a pilot study. [2021]

12. Spain pubmed.ncbi.nlm.nih.gov

Clinical pain evaluation with intraoral vibration device during local anesthetic injections. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The efficacy of 95-Hz topical vibration in pain reduction for trigger finger injection: a placebo-controlled, prospective, randomized trial. [2021]

14. Turkey pubmed.ncbi.nlm.nih.gov

[Reduction of pain during intravenous cannulation in children: Buzzy application]. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Vibratory stimulation increase the electro-cutaneous sensory detection and pain thresholds in women but not in men. [2018]