| NCT ID | NCT07423377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2026-03-19 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fibromyalgia is the most common centralized pain disorder, affecting up to 3% of the population. Current treatments are incompletely effective, often poorly tolerated, and costly: there remains an urgent need for novel, effective, and well-tolerated therapy. Preliminary data suggests that vestibulocortical stimulation (VCS), or irrigating the external ear canal with temperate water, could rapidly improve pain and quality of life in this cohort. The VIPR trial will assess the efficacy of a single session of VCS - a safe \& cost-effective bedside technique using a plastic syringe and temperate water - relative to sham in treating pain \& improving quality of life using validated patient-reported outcomes.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Age equal to or \>18 years old * Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure. * Owns or has access to a smart phone or computer to complete outcome measures * Fluency in English * Diagnosis of Fibromyalgia (FM) * Diagnosis by American College of Rheumatology 2016 questionnaire * Pain score 4/10 or more and less than 10/10 on the numeric rating scale at the time of inclusion. Exclusion Criteria: * History of tympanic membrane injury, rupture, or surgery a. Including tympanostomy, or "ear tubes," and/or cochlear implant. * Right ear infection within the last 3 months, or current right ear pain. * Current pregnancy * Bipolar Disorder * History of seizures (including non-epileptiform seizures) * History of syncope within the last 3 months. a. Not including presyncope or in setting of known medical illness (i.e., heatstroke) * Inability to lay supine for 15 minutes * Receiving disability benefits for fibromyalgia or involved in litigation related to fibromyalgia. * Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study. * History of or current Meniere's Disease * History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last 3 months * History of hospitalization for severe hypertension * History of vestibular schwannoma or meningioma resection. * Patients taking opioid therapy (not including tramadol).
Contact & Investigator
Michael Kaplan, MD
PRINCIPAL INVESTIGATOR
Mount Sinai Hospital, Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT07423377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07423377 currently recruiting?
Yes, NCT07423377 is actively recruiting participants. Contact the research team at viptrial@mountsinai.org for enrollment information.
Where is the NCT07423377 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07423377 clinical trial?
NCT07423377 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Michael Kaplan, MD at Mount Sinai Hospital, Icahn School of Medicine. The trial plans to enroll 56 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.