Cost-effectiveness of a smartphone app for tinnitus treatment
Cost-effectiveness of a Smartphone Application for Tinnitus Treatment (The CATT Trial): A Study Protocol of a Randomised Controlled Trial
This study tests if a smartphone app can help adults with tinnitus manage their symptoms better and more affordably than regular clinic care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT05245318 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and cost-efficiency of a smartphone application designed to enhance therapy compliance and provide tinnitus counseling as part of a blended physiotherapy program. It involves a single-blind, two-arm randomized control trial comparing this app-based approach to standard clinical care for adults diagnosed with somatic tinnitus. Participants will be recruited from the Ear Nose Throat department of the Antwerp University Hospital and will be randomly assigned to either the smartphone application group or the standard care group. The study seeks to determine if the app can deliver comparable or superior outcomes in managing tinnitus symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a diagnosis of somatic tinnitus who are fluent in Dutch and can use a smartphone.
Not a fit: Patients with other types of tinnitus, active middle ear pathology, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and effective treatment option for patients suffering from tinnitus.
How similar studies have performed: While there is ongoing research in the area of digital health interventions for tinnitus, this specific approach combining a smartphone app with physiotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (+ 18 years old) with Somatic tinnitus (ST), diagnosed according to the diagnostic criteria for ST * Fluent in Dutch * Own smartphone and able to use common applications without support Exclusion Criteria: * Other types of tinnitus * Active middle ear pathology * An active psychiatric disorder (such as anxiety disorder or clinical depression) diagnosed by the psychiatric team of Antwerp University Hospital
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: Sarah Michiels, PhD
- Email: sarah.michiels@uhasselt.be
- Phone: +3211269307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.