High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Treatments: Oxytocin

Criteria

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 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, CHF, and severe renal disease.