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NCT03365011 · ClinicalTrials.gov registry record · Phase 4
Nitrous Oxide Treatment for Tinnitus
A Phase 4 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT03365011: Completed Phase 4 study, sponsored by Washington University School of Medicine.
NCT03365011 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03365011, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
Tinnitus is perception of sound without the presence of an external acoustic stimulus. Approximately 50 million Americans experience chronic tinnitus and of these, 10 million have bothersome tinnitus. The tinnitus research literature suggests that NMDA receptor antagonists may prove to be useful in reducing tinnitus. Nitrous oxide, a member of the NMDA receptor antagonist class, is a widely-used general anesthetic and sedative with a proven safety profile. The investigators hypothesized that the administration of nitrous oxide, an NMDA receptor antagonist, may be effective in treatment of tinnitus. The study design was a randomized placebo-controlled crossover trial.
Primary Outcome
Change of participant-reported tinnitus symptoms 1 week after each intervention. The Tinnitus Functional Index (TFI) is a 25-question survey assessing tinnitus impact on quality of life. Participants were asked to rate on a scale from 0-10 the degree of unpleasantness, cognitive interference, sleep disturbance, auditory difficulties, interference with relaxation, and emotional distress associated with their tinnitus. Subscores are summed and scaled to a score of 0-100. A score less than 25 indi
Interventions
- DRUG Nitrous oxide gas for inhalation
- DRUG Placebo gas for inhalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-07 |
| Phase | Phase 4 |
What the finished NCT03365011 record still lists
NCT03365011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Nitrous oxide gas for inhalation is the first listed.
NCT03365011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03365011 about?
NCT03365011 is a clinical study titled "Nitrous Oxide Treatment for Tinnitus". Tinnitus is perception of sound without the presence of an external acoustic stimulus. Approximately 50 million Americans experience chronic tinnitus and of these, 10 million have bothersome tinnitus. The tinnitus research literature suggests that NMDA receptor antagonists may prove to be useful in ...
What is the current status of trial NCT03365011?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2016-10. Estimated completion is 2017-07.
What interventions are being tested in trial NCT03365011?
The interventions under investigation include: Nitrous oxide gas for inhalation (DRUG), Placebo gas for inhalation (DRUG).
Who is sponsoring clinical trial NCT03365011?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03365011's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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