Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05004194
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old with ability to comprehend and consent to protocol.
* Diagnosis of fibromyalgia by American College of Rheumatology (ACR) criteria (questionnaire).
* At least a 4/10 baseline on the visual analogue pain scale (VAS).
* Stable fibromyalgia medications for at least 4 weeks.
* Owns or has access to a smart phone or computer to complete outcome measures.
Exclusion Criteria:
* Use of opioids
* Otitis externa or media within the past six months.
* Current ear pain with or without other symptoms of otitis externa.
* History of tympanic membrane rupture or surgery.
* Current pregnancy.
* Inability to lay supine for 30 minutes.
* Limited decision making capacity.
* Engaged in litigation, currently or prior, related to FMS.
* Inability to commute to clinic once.
* Primary language not English.
* Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study
* Treatment with the medication meclizine for vertigo
* History of seizures
* Diagnosis of bipolar disorder (treated or untreated)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05004194
Study Brief:
Protocol Section:
NCT05004194