Tinnitus suppression with electrical stimulation in subjects with Single Sided Deafness

Completed

Conditions: phantom sensation of sound
tinnitus
10022396

Registration Number: NL-OMON39325

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Ipsilateral: severely hearing-impaired (PTA more than 80 dB)
- Contralateral: moderate to normal hearing (PTA better than 50 dB). In cases of
moderate hearing: PTA with hearing aid should be better than 20 dB.
- Experiencing tinnitus which is:
o Continuous
o Ipsilaterally localized
o Characterized as a pure tone
o Severe, that is:
o Visual Analogue Scale-score > 7,
o Tinnitus Handicap Inventory-score > 36 and/or Tinnitus Questionnaire- score > 41
o Stable (present > 2 years, stable > 1 year)
o No benefit from a hearing aid
- Willingness to participate in this research (informed consent)

Exclusion Criteria

- Pulsatile tinnitus
- History of psychiatric or neurological disorders or depression: Beck Depression
Inventory score should not be 20 or higher
- Use of antidepressant medication
- Cochleovestibular neurovascular conflict
- Any congenital deafness (e.g. absence of a cochlear nerve)
- History of vestibular schwannoma
- Ossified cochlea
- Active middle ear disease
- Age < 18 years old

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(this text is taken from the protocol)<br /><br><br /><br>The primary study variable is the intensity of the experienced tinnitus and is<br /><br>measured using Visual Analogue Scales. VAS will be used because it is a quick<br /><br>measurement which is often used in comparable studies. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(this text is taken from the protocol)<br /><br><br /><br>Because tinnitus is a subjective phenomenon, its intensity and impact are<br /><br>further identified by means of questionnaires (Tinnitus Questionnaire and<br /><br>Tinnitus Handicap Inventory) and audiological tests (Tinnitus Loudness Matching<br /><br>and Residual Inhibition) which have a more objective character. These secondary<br /><br>endpoints will give additional information which is desirable because of the<br /><br>subjectivity of this phenomenon and provides more certainty. </p><br>