Status:
COMPLETED
UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)
Lead Sponsor:
UNITI Consortium
Collaborating Sponsors:
University Hospital Regensburg
University Hospital Virgen de las Nieves
Conditions:
Tinnitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different types of interventions (hearing aids, sound therapy, structured counseling, cognitive behavioral therapy) e...
Detailed Description
The study will be conducted as a randomized controlled trial (RCT), which investigates the effect of four different tinnitus therapy approaches applied over a time period of 12 weeks as a single or ra...
Eligibility Criteria
Inclusion
- Primary complaint tinnitus
- Chronic tinnitus (for at least 6 months based on history)
- Age 18-80 years
- Ability to understand and consent to the research / ability to participate (hearing ability, intellectual capacity, no plans for sabbaticals or long-term holidays, no (plans for) pregnancy)
- A score of \>22 on the Montreal Cognitive Assessment (MoCa), i.e. adults without mild cognitive impairment
- Ability and willingness to use the UNITI mobile applications on their smartphones
- A score of ≥ 18 in the Tinnitus Handicap Inventory (THI) of Newman et al. (1996)
- Willing to use a hearing aid (if indication)
- If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
Exclusion
- Objective tinnitus / heartbeat-synchronous tinnitus as primary complaint
- Start of any other tinnitus related treatments, especially hearing aids, structured counseling, sound therapy (with special devices; expecting long term effects) or cognitive behavioral therapy in the last 3 months before the start of the study
- Otosclerosis / acoustic neuroma or other relevant ear disorders with fluctuation hearing
- Present acute infections (acute otitis media, otitis externa, acute sinusitis)
- Meniere's disease or similar syndromes (but not vestibular migraine)
- Serious internal, neurological or psychiatric conditions
- Epilepsy or other CNS disorders (brain tumor, encephalitis)
- Clinically relevant drug, medication or alcohol abuse up to 12 weeks before study start
- Missing written informed consent
- Severe hearing loss - inability to communicate properly in the course of the study
- One deaf ear
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04663828
Start Date
April 16 2021
End Date
June 15 2023
Last Update
August 14 2023
Active Locations (1)
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1
Tinnituszentrum Regensburg
Regensburg, Bavaria, Germany, 93053