NCT07567274Enrolling by invitationPhase 2
DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury
Single-Arm Pilot Study of Compounded DMSO-Based Dual-Route Therapy for Refractory Subjective Tinnitus in PASC and Post-COVID-19 Vaccine Injury
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 May 2026
- Start date
- 15 May 2026
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Leading Edge Clinic
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07567274
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 15 May 2026 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent exposure (within the past 3 months) to known ototoxic medications associated with new or rapidly worsening tinnitus.
Other illness
- Active middle-ear infection, acute otitis media, tympanic membrane perforation, or current otorrhea.
- Known hypersensitivity or allergy to dimethyl sulfoxide (DMSO) or any component of the study formulations (betahistine, dexamethasone, lidocaine, levocarnitine, N-acetylcysteine, or excipients).
- 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.
- Any other otologic or neurologic condition judged by the investigator to confound tinnitus assessment or pose unacceptable risk with DMSO-based therapy.
Other
- Objective or pulsatile tinnitus, or tinnitus primarily synchronous with the heartbeat.
- Pregnancy or breastfeeding.
- Inability to comply with study procedures, including telemedicine visits, electronic data capture, or topical/otic dosing instructions.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nationwide Telemedicine Study (Leading Edge Clinic) Coordinator of this site? Confirm its status | Ithaca | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.