CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Nitrous oxide gas for inhalation +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03365011
NCT03365011Phase 4Completed

Nitrous Oxide as Treatment for Tinnitus: A Randomized Crossover Trial

Washington University School of Medicine·interventional·Posted Dec 7, 2017·Updated Dec 14, 2018

In Brief

A Phase 4 clinical trial evaluating Nitrous oxide gas for inhalation and Placebo gas for inhalation for Tinnitus. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 7, 2017
Enrollment StartOct 1, 2016
Primary CompletionJun 1, 2017
Study CompletionJul 1, 2017
TodayJul 1, 2026
Enrollment to primary: 8 monthsPosted 8.6 years ago

Interventions

Nitrous oxide gas for inhalationdrug

Nitrous oxide gaseous mixture (50% nitrous oxide and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.

Placebo gas for inhalationdrug

Placebo gaseous mixture (50% nitrogen and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.