Chronic tinnitus associated with mild hearing loss Ear, Nose and Throat
Conditions
Interventions
Participants are randomly allocated in a double-blind manner to one of three treatment groups for a 12-week intervention period.
Arm 1 (placebo control):
Participants receive placebo amplification th
Sponsors
AFREPA (Association Française Equipe Pluridisciplinaire Acouphène)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults seeking clinical care for tinnitus as the primary complaint 2. Continuous bilateral or centrally perceived tinnitus present for at least 3 months 3. Mild bilateral hearing loss meeting one of the predefined eligible audiometric profiles 4. Disabling tinnitus, defined as a score =38 on the French version of the Tinnitus Handicap Inventory (THI) 5. Ability and willingness to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Identifiable otolaryngological disorder explaining the tinnitus 2. Hearing loss not meeting the predefined eligible audiometric profiles 3. Use of hearing aids, sound generators, or combination devices within the previous 12 months 4. Any condition likely to interfere with study participation or outcome assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus distress measured using the Tinnitus Functional Index (TFI) at 6 and 12 weeks;Global overall improvement measured using the Global Rating Change Scale, a clinical meaningful change was defined as at least a slight improvement in the overall condition following therapy, at 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Auditory functioning measured using the Speech, Spatial and Qualities of Hearing Scale – Short Form at 6 and 12 weeks;Anxiety and depression measured using the Hospital Anxiety and Depression Scale at 6 and 12 weeks;Tinnitus annoyance and intensity measured using Visual Analog Scales at 6 and 12 weeks;Quality of life measured using SF12-v2 at 6 and 12 weeks | — |
Countries
France
Contacts
Public ContactPhilippe Fournier
Outcome results
None listed