Normal hearing tinnitus sound therapy
| ISRCTN | ISRCTN27770434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27770434 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/03/2015
- Registration date
- 21/04/2015
- Last edited
- 24/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
There are plenty of studies that investigate how relief sounds for tinnitus sound therapy work for patients with hearing loss. The purpose of this study is to see how sounds can be used effectively with normal-hearing patients, using the Tinnitus Retraining Therapy (TRT) treatment approach.
Who can participate?
Normal-hearing patients with tinnitus symptoms can participate if they are between age 18-75.
What does the study involve?
The study involves the patient coming to a tinnitus clinic and being fit with a set of hearing aids that have a built-in sound generator (combination device). Patients will all follow the TRT fitting and treatment protocol and they will be asked to fill out questionnaires at a 3-month and a 6-month visit. Patients will be fit using non-traditional relief sounds and the results will be compared to patients who have been fitted with white noise relief sound.
What are the possible benefits and risks of participating?
The benefit is the elimination or reduction of tinnitus symptoms in patients with normal hearing. The risk may possibly be prolonged exposure to loud sounds. Patients will be counseled on the safe use of devices and how to avoid excessive noise exposure during the study. The risk is minimal.
Where is the study run from?
Fondazione Ascolta e Vivi (Italy).
When is the study starting and how long is it expected to run for?
From May to December 2015.
Who is funding the study?
Oticon A/S in Denmark and the Oticon filial in Italy.
Who is the main contact?
Luca Del Bo
Contact information
Scientific
Fondazione Ascolta e vivi
Del Bo Tecnologia per l'ascolto
Via Lanzone 36
Milano
20123
Italy
Study information
| Study design | Interventional single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Normal hearing tinnitus sound therapy: an interventional single-centre study |
| Study objectives | The aim of this study is to investigate whether or not Tinnitus Retraining Therapy (TRT) using complex sounds such as red noise or pink noise or other sounds provided by the open ear hearing aids (Oticon Alta2 Pro Ti) can be equally or more effective in the rehabilitation of tinnitus than the classical white noise sound generator for a subgroup of patients with normal hearing up to at least 2 kHz. |
| Ethics approval(s) | Fondazione Ascolta e vivi (FAEV) (Internal Scientific Board) – approval pending |
| Health condition(s) or problem(s) studied | Normal hearing persons with tinnitus symptoms |
| Intervention | 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 noise, nature sounds, modulated sounds). All sounds are integrated in a sound generator which is part of an Oticon Alta2 Pro Ti hearing aid. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 outcome measures | New sounds: red or pink noise, modulated sounds, and/or ocean sounds are appreciated and preferred by patients |
| Overall study start date | 01/05/2015 |
| Completion date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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) |
| Key exclusion criteria | All tinnitus aetiology excluding: Meniere, middle-external ear desease, somatosensory tinnitus under physical therapy |
| Date of first enrolment | 07/04/2015 |
| Date of final enrolment | 01/08/2015 |
Locations
Countries of recruitment
- Italy
Study participating centre
Italy
Sponsor information
Industry
Kongebakken 9
Smoerum
2765
Denmark
"ROR" |
https://ror.org/05mwsq745 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2017 | 24/01/2019 | Yes | No |
Editorial Notes
24/01/2019: Publication reference added
