DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury

Enrolling by invitation · Phase 2

Conditions studied: Tinnitus

In brief

The goal of this clinical trial is to test a compounded dimethyl sulfoxide (DMSO)-based dual-route therapy for adults with refractory subjective tinnitus linked to long-COVID (post-acute sequelae of SARS-CoV-2) or post-COVID-19 vaccine injury. Participants have bothersome tinnitus that has not improved with at least two prior standard treatments. All participants will receive two study treatments for 30 days: a DMSO-based ear canal liquid and a DMSO-based transdermal cream applied to the skin around the ears and upper neck. The ear drops are used every 4 days, and the cream is applied once daily at bedtime. Both formulations are prepared by a licensed compounding pharmacy. The main question is whether at least half of the participants achieve a 50% or greater reduction in their Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Researchers will also look at changes in tinnitus loudness and annoyance, sleep and concentration, other symptoms such as vertigo, insomnia, headache, and fatigue, and any side effects. After an initial in-person ear, nose, and throat (ENT) evaluation, all study visits are conducted by telemedicine. Participants complete electronic questionnaires through a secure, HIPAA-compliant system over 12 months of follow-up.

Key facts

Study ID

NCT07567274

Run by

Leading Edge Clinic

People needed

20

Starts

2026-05-15

Expected to finish

2027-05-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• Adults 18 to 70 years of age.
• Chronic subjective non-pulsatile tinnitus for at least 6 months.
• Bothersome tinnitus defined by a Tinnitus Handicap Inventory (THI) score ≥ 20 at screening.
• Documented history of post-acute sequelae of SARS-CoV-2 (PASC, long COVID) or post-COVID-19 vaccine injury, with tinnitus onset or clear worsening temporally associated with that event.
• Failure of at least two prior tinnitus therapies (for example, sound therapy, counseling or cognitive-behavioral approaches, pharmacologic treatments, or steroid therapy).
• Willing and able to provide informed consent.
• Able to complete telemedicine visits and electronic questionnaires in English and to attend a baseline in-person otolaryngology (ENT) evaluation.

You may not qualify if…

• Objective or pulsatile tinnitus, or tinnitus primarily synchronous with the heartbeat.
• Active middle-ear infection, acute otitis media, tympanic membrane perforation, or current otorrhea.
• Recent exposure (within the past 3 months) to known ototoxic medications associated with new or rapidly worsening tinnitus.
• Known hypersensitivity or allergy to dimethyl sulfoxide (DMSO) or any component of the study formulations (betahistine, dexamethasone, lidocaine, levocarnitine, N-acetylcysteine, or excipients).
• Pregnancy or breastfeeding.
• Uncontrolled or severe psychiatric illness (for example, active psychosis, acute suicidality) that, in the opinion of the investigator, would interfere with participation or completion of questionnaires.
• Inability to comply with study procedures, including telemedicine visits, electronic data capture, or topical/otic dosing instructions.
• Any other otologic or neurologic condition judged by the investigator to confound tinnitus assessment or pose unacceptable risk with DMSO-based therapy.

Where it is running

• Nationwide Telemedicine Study (Leading Edge Clinic) — Ithaca, New York, United States

Full record on ClinicalTrials.gov

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