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NCT04731935 · ClinicalTrials.gov registry record · NA
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
A NA study, sponsored by Spark Biomedical.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04731935: Completed NA study, sponsored by Spark Biomedical.
NCT04731935 is a NA study that has completed, run by Spark Biomedical. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731935, a NA study, has completed, sponsored by Spark Biomedical.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
Primary Outcome
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate sev
Interventions
- DEVICE Sparrow Therapy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2021-05-26 |
| Phase | NA |
What the finished NCT04731935 record still lists
NCT04731935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Sparrow Therapy System is the first listed.
NCT04731935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04731935 about?
NCT04731935 is a clinical study titled "Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal". The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
What is the current status of trial NCT04731935?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2021-03-18. Estimated completion is 2021-05-26.
What interventions are being tested in trial NCT04731935?
The interventions under investigation include: Sparrow Therapy System (DEVICE).
Who is sponsoring clinical trial NCT04731935?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04731935's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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