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Normal hearing tinnitus sound therapy

Normal hearing tinnitus sound therapy: an interventional single-centre study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27770434
Enrollment
20
Registered
2015-04-21
Start date
2015-04-07
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal hearing persons with tinnitus symptoms Ear, Nose and Throat Tinnitus

Interventions

The intervention is the type of tinnitus relief sound used in the treatment of tinnitus. In this study, the plan is to compare traditional white noise to non-traditional relief sounds (pink noise, red

Sponsors

Oticon A/S
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: All tinnitus aetiology excluding: Meniere, middle-external ear desease, somatosensory tinnitus under physical therapy

Design outcomes

Primary

MeasureTime frame
1. Demonstrate that the Oticon device is at least as effective as other combination/sound generator devices that are used currently 2. Demonstrate that the Oticon device is more effective than other combination/sound generator devices that are used currently In other words, to understand what makes the Ti different (better?) in comparison with other devices.

Secondary

MeasureTime frame
New sounds: red or pink noise, modulated sounds, and/or ocean sounds are appreciated and preferred by patients

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026