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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT07037134
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of fibromyalgia syndrome, documented in the medical record provided by the participant prior to enrollment.
* Moderate or greater pain intensity during the preceding week, defined as a score higher than 3 on an 11-point Numeric Rating Scale.
* Normal hearing confirmed by a hearing test, defined as a mean threshold of ≤ 20 dB HL at 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz.
* Ability to communicate in Spanish.
* Provision of signed written informed consent to participate in the research.
Exclusion Criteria:
* A diagnosis of misophonia or auditory processing disorders, as documented in the participant's medical record.
* Concurrent neuropathic or acute pain.
* Severe cognitive impairment, defined as a Mini-Mental State Examination score ≤ 17.
* Severe psychiatric disorders in the symptomatic phase.
* History of substance abuse in the past 12 months or current substance use disorder as reported by the participant.
* Changes in ongoing therapy during or within one month prior to study enrollment per participant self-reports.
* Central nervous system disorders.
* Any other serious or unstable medical condition that could interfere with study participation.
* Known allergies or hypersensitivity to study materials.
* Pregnancy, lactation, or being within three months postpartum at the time of study enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07037134
Study Brief:
Protocol Section:
NCT07037134