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SONATA : Study on the advantage of Two CI-Aids, a randomized controlled study

SONATA : Study on the advantage of Two CI-Aids, a randomized controlled study - SONATA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39995
Enrollment
58
Registered
2012-01-20
Start date
2013-08-29
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

deafness sensorineural hearing loss

Interventions

Bilateral cochlear implantation.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18. 2. Postlingual onset of hearing loss, defined as an onset of hearing loss >= 6 years of age. 3. Sensorineural hearing loss of a severe or greater degree in both ears, defined as pure tone average (250, 500, 1000, 2000 Hz) >= 70 dB HL with no signs of a ski-slope audiogram. 4. Duration of severe-to-profound hearing loss 30 dB in the past year. 6. Marginal hearing aid benefit with hearing aids, defined as speech perception

Exclusion criteria

Exclusion criteria: 1. Previous implant experience. 2. Disability which could interfere with the completion of all tests. 3. Abnormal cochlear anatomy in one or both ears. 4. Chronic ear infection in one or both ears. 5. Psychosocial contraindication

Design outcomes

Primary

MeasureTime frame
The main outcome will be the performance on the Amsterdam-Oldenburg Bilateral Benefit Battery for cochlear implants (AO-BBB-ci) test battery. This test battery evaluates the performance for speech perception in background noise with a spatial separation between the sound sources, horizontal localization, and listening effort.

Secondary

MeasureTime frame
Secondary outcome measures will be self-reported benefits in everyday listening situations assessed with the Speech, Spatial and Qualities Hearing Scale (SSQ), generic quality of life questionnaire scores (Health Utilities Index, HUI) and disease specific quality of life questionnaire scores (Nijmegen Cochlear Implant Questionnaire, NCIQ, and Tinnitus Handicap Inventory (THI).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)