ormal hearing tinnitus sound therapy
Completed
- Conditions
- ormal hearing persons with tinnitus symptomsEar, Nose and ThroatTinnitus
- Registration Number
- ISRCTN27770434
- Lead Sponsor
- Oticon A/S
- Brief Summary
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29336133 (added 24/01/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Normal hearing or hearing loss not more than 25 dB between 250 Hz and 2 kHz
2. Minimum 6 months tinnitus (no upper limit)
3. Category 1 (Jastreboff & Hazell, 2004) patients with normal hearing and severe tinnitus
4. Age 18-75 years
5. Inclusion of mono or bilateral tinnitus and with moderate hyperacusis (up to 6 in VAS scale), exclusion of pathological severe anxiety and depression (THI >= 80)
Exclusion Criteria
All tinnitus aetiology excluding: Meniere, middle-external ear desease, somatosensory tinnitus under physical therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Demonstrate that the Oticon device is at least as effective as other combination/sound generator devices that are used currently<br> 2. Demonstrate that the Oticon device is more effective than other combination/sound generator devices that are used currently<br><br> In other words, to understand what makes the Ti different (better?) in comparison with other devices.<br>
- Secondary Outcome Measures
Name Time Method ew sounds: red or pink noise, modulated sounds, and/or ocean sounds are appreciated and preferred by patients