Status:
COMPLETED
Nitrous Oxide Treatment for Tinnitus
Lead Sponsor:
Washington University School of Medicine
Conditions:
Tinnitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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....
Detailed Description
Subjective, idiopathic, non-pulsatile tinnitus ("tinnitus") is perception of sound without the presence of an external acoustic stimulus. Approximately 50 million Americans experience chronic tinnitus...
Eligibility Criteria
Inclusion
- Adult men and women 18-65 years of age
- Subjective, unilateral or bilateral, non-pulsatile tinnitus scoring "Bothered more than a little but not a lot", "Bothered a lot", or "Extremely bothered" on the Global Bothersome scale
- Able to give informed consent
- Must be able to read, write, and understand English
Exclusion
- Bipolar disorder
- Schizophrenia
- Schizoaffective disorder
- Substance abuse or dependence (except for remote substance abuse or dependence with remission at least 1 year prior to the study and except for nicotine use disorders)
- Acute medical illness that may pose subject at risk during nitrous oxide administration
- Active psychotic symptoms
- Patients with significant pulmonary disease and/or requiring supplemental oxygen
- Contraindication against the use of nitrous oxide:
- Pneumothorax
- Bowel obstruction
- Middle ear occlusion
- Elevated intracranial pressure
- Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
- Pregnant patients
- Breastfeeding women
- Previous administration of NMDA-receptor antagonists (e.g., ketamine) within the last 3 months
- Tinnitus related to cochlear implantation, retrocochlear lesion, Meniere's Disease, or other known anatomic lesions of the ear or temporal bone
- Tinnitus related to a Workman's Compensation claim or litigation-related event that is still pending.
- Any medical condition, which, in the opinion of the PI, confounds study results or places the subject at greater risk
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03365011
Start Date
October 1 2016
End Date
July 1 2017
Last Update
December 14 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110