Condition category
Ear, Nose and Throat
Date applied
24/10/2017
Date assigned
31/10/2017
Last edited
31/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A large number of acoustic therapies (sound therapy) are used to treat tinnitus (a condition where a person hears sounds that come from inside the body). At present, the only way to evaluate acoustic therapies is by means of subjective methods such as analog visual scale and questionnaires. This study, consequently, seeks to establish an objective methodology to treat tinnitus with acoustic therapies based on electroencephalographic (EEG) activity recordings (the recordings of the electrical activity in the brain). The aim of this study is to examine how acoustic therapies can improve the quality of life and is there is way to correlate the objective and subjective data from patients EEGs and questionnaires.

Who can participate?
Patients aged 18 with tinnitus.

What does the study involve?
Participants are randomly allocated to one of five groups. There are four acoustic therapy groups and one control group. Participants in the acoustic therapy groups, each group using different acoustics and effects, undergo EEG recordings at the beginning of the treatment, one week of treatment, five weeks of treatment and at eight weeks of treatment. Those in the control group listen to relaxing music and do not receive any acoustic therapy. Participants are assessed for their effectiveness of the treatments.

What are the possible benefits and risks of participating?
Participants may benefit from decreases in their tinnitus symptoms. There are no expected risks however it could increase the tinnitus symptoms.

Where is the study run from?
Tecnológico de Monterrey (Mexico)

When is the study starting and how long is it expected to run for?
June 2016 to December 2017

Who is funding the study?
Tecnológico de Monterrey (Mexico)

Who is the main contact?
Dr Luz María Alonso Valerdi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luz María Alonso Valerdi

ORCID ID

Contact details

TEC MONTERREY
Monterrey Institute of Technology and Higher Education
Eugenio Garza Sada 2501
Monterrey
64849
Mexico

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CONBIOETICA19CEI00820130520

Study information

Scientific title

Electroencephalographic evaluation of acoustic therapies for the treatment of chronic and refractory tinnitus

Acronym

Study hypothesis

Research questions:
1. How can acoustic therapies improve the quality of patients ́life?
2. How can we correlate objective and subjective data from patients EEG and questionnaires?

Ethics approval

1. Research Ethics Committee of Escuela de Medicina del Instituto Tecnológico y de Estudios Superiores de Monterrey, 20/06/2016, ref: COFEPRIS register number 13CEI19039139
2. Research Committee of Escuela de Medicina del Instituto Tecnológico y de Estudios Superiores de Monterrey with the National Commission of Bioethics register number, 20/06/2016, refs: COFEPRIS register number 13CI19039138 and CONBIOETICA19CEI00820130520

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic and Refractory Tinnitus

Intervention

Participants are randomly allocated to one of five different acoustic therapies (control and 4 other standard ones).

The acoustic therapies used in the study are the ones found up to now as the most effective. These are tinnitus retraining therapy, auditory discrimination therapy, tinnitus retraining therapy, therapy for enriched acoustic environment, and binaural. All of them are acoustically different and reach different effects. For example, binaural therapy attempts to reduce the stress level and thereby to reduce the tinnitus perception. Auditory discrimination therapy attempts to redirect the patient attention towards therapy instead to tinnitus, and thus diminishing the mental resources used to perceive tinnitus.

The control therapy includes relaxing music instead of any acoustic therapy. It is used as reference to compare the other acoustic therapies.

All participants are made aware of the procedure and signed a consent form. Acoustic therapies are personalized for each patient and their head physician followed-up the experiment. Participants are instructed to use their therapies every day for one hour, at any time of the day. Assistance during the experiment are provided.

In 1st step, evoked activity are considered (EEG data recorded in passive mode) since auditory ERPs have been formerly investigated in patients with tinnitus, as well as in those with tinnitus treated with acoustic therapies. For each experimental session in passive mode, patients will be asked to close their eyes, relax and pay attention to their stimulus. All the stimuli are 1 second long, repeated 50 times, and have an inter-stimulus interval of 2.5 seconds.

In the 2nd step of the same session, active mode is recorded. A usual acoustic environment are played, whilst five associated auditory stimuli are randomly played. Participants are instructed to identify the randomized stimuli by pressing a keyboard button. The three acoustic environments along with their related stimuli in each session are standardised to 1 second and repeated 50 times at a random rate.

In total, four sessions are recorded: at the beginning of the experiment, at one week of treatment, at five weeks of treatment, and at eight weeks of treatment.

To record the data, 17 EEG channels are recorded at 256Hz by using the g.USBamp (g.tec medical enginnering, Austria).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Effectiveness of each therapy is assessed using the EEG registration at the beginning of the procedure, one week after beginning, five weeks after beginning, and eight weeks.

Secondary outcome measures

State and therapy effectiveness is measured using validated patient questionnaires at week one, week five and week eight.

Overall trial start date

20/06/2016

Overall trial end date

22/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients adults (>18 years old)
2. Accept voluntarily to participate in the project
3. Sign a consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75 patients, to have 5 groups (15 patients per group)

Participant exclusion criteria

1. Without any history of otitis
2. Cerebellopontine angle tumours
3. Psychiatrist pathologies
4. Demyelinating diseases of the nervous system
5. Epilepsy

Recruitment start date

01/07/2017

Recruitment end date

20/11/2017

Locations

Countries of recruitment

Mexico

Trial participating centre

Tecnologico de Monterrey
Mexico City
14380
Mexico

Trial participating centre

Instituto Nacional de Rehabilitación (INR)
Mexico City
14389
Mexico

Sponsor information

Organisation

Tecnológico de Monterrey

Sponsor details

Monterrey Institute of Technology and Higher Education
Eugenio Garza Sada 2501
Monterrey
64849
Mexico

Sponsor type

University/education

Website

http://tec.mx

Funders

Funder type

Government

Funder name

Instituto Tecnológico y de Estudios Superiores de Monterrey

Alternative name(s)

Tecnológico de Monterrey, Tec de Monterrey, ITESM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Mexico

Results and Publications

Publication and dissemination plan

This protocol was submitted to the "BMC Ear, Nose and Throat Disorders" and is pending to be published.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date. Once we have completed our registrations (possibly by the end of this year) and we have published our first results (possibly by June 2018), we’ll share our databases.

Intention to publish date

01/03/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes