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
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
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