A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Study Overview
Brief Summary
The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.
Detailed Description
This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose & Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.
- •Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of >
- •Subjects must have tinnitus loudness rating of >4/10.
Exclusion Criteria
- •Subjects who are being treated for tinnitus < 6 months due to the acute nature of their condition
- •Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale.
- •Those with tinnitus of a muscular or vascular etiology
- •Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray.
- •Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions.
- •Subjects who suffer from migraines.
- •Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.
Arms & Interventions
high-dose intranasal oxytocin
Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.
Intervention: Oxytocin (Drug)
Nasal spray
Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.
Intervention: Placebo nasal spray (Other)
Outcomes
Primary Outcomes
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Time Frame: Baseline, Week 9
Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness. No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3.
Secondary Outcomes
No secondary outcomes reported