Tinnitus suppression with electrical stimulation in subjects with Single Sided Deafness

Tinnitus suppression with electrical stimulation in subjects with Single Sided Deafness - Tinnitus suppression using cochlear implants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39325

Enrollment

Registered

2012-05-22

Start date

2012-08-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

phantom sensation of sound tinnitus

Interventions

(this text is taken from the protocol, for the detailed version or a schematic overview (Flow-chart and table 1) see protocol) Through a standard surgical procedure subjects will receive a CI in the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
(this text is taken from the protocol) The primary study variable is the intensity of the experienced tinnitus and is measured using Visual Analogue Scales. VAS will be used because it is a quick measurement which is often used in comparable studies.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)