NOICE Device for Pain
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.12345
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.678910
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.1112131415
What is the purpose of this trial?
This is a prospective, randomized, crossover study on healthy volunteers evaluating the impact of spatial audio on heat pain threshold (HPT). The primary center for this study will be Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA) and other Stanford affiliated sites.
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a crossover study to evaluate the impact of spatial audio on heat pain threshold using the NOICE device
Follow-up
Participants are monitored for device satisfaction, anxiety levels, and system usability immediately after each intervention
Treatment Details
Interventions
- NOICE device
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Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor