Condition category
Ear, Nose and Throat
Date applied
23/03/2015
Date assigned
21/04/2015
Last edited
16/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Engineer Luca Del Bo

ORCID ID

Contact details

Fondazione Ascolta e vivi
Del Bo Tecnologia per l'ascolto
Via Lanzone 36
Milano
20123
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

Fondazione Ascolta e vivi (FAEV) (Internal Scientific Board) – approval pending

Study design

Interventional single-centre study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2015

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

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

Recruitment start date

07/04/2015

Recruitment end date

01/08/2015

Locations

Countries of recruitment

Italy

Trial participating centre

Fondazione Ascolta e Vivi
Italy

Sponsor information

Organisation

Oticon A/S

Sponsor details

Kongebakken 9
Smoerum
2765
Denmark

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Oticon A/S (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes