High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

Phase 3

Terminated

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.

Recruitment & Eligibility

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 > 16.
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.

Arm && Interventions

Group	Intervention	Description
Nasal spray	Placebo 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.
high-dose intranasal oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness	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 Outcome Measures