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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT06880367
Eligibility Criteria:
Inclusion Criteria:
* Person who agreed to participate in the study and gave consent
* Aged ≥ 18 years and \< 85 years
* Suffering from subjective tinnitus for more than 3 months
* Have a score on the THI questionnaire taken at T0 greater than or equal to 38
* Be equipped with a smartphone compatible with the Siopi application and a computer connection for videoconference sessions
* Have answered the questionnaires on the Siopi application: THI, VAS-D and associated questions and insomnia severity index
* Have committed to diligently following the study protocol, including independent training
* Have agreed not to take other new treatments for tinnitus throughout the duration of the study
* Able to understand and carry out assessment instructions.
Exclusion Criteria:
* Patient suffering from objective tinnitus
* Current port of white noise generators
* Patient having consulted phoniatrics more than twice or having participated in more than two sound-mediated workshop sessions
* Bilateral hearing loss \> 40 dB uncorrected on an audiogram or having declared serious or severe hearing loss on Siopi questionnaire, with or without prosthetic correction
* New therapy introduced less than 2 months ago
* Psychatric disorders causing auditory hallucinations
* Protected person (under guardianship or curatorship)
* Person under judicial protection
* Person deprived of liberty
* Person not affiliated to a social security system
* Pregnant or breastfeeding woman
* Person participating in a drug study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT06880367
Study Brief:
Protocol Section:
NCT06880367