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*CART sound therapy* for tinnitus relief in Nucleus® cochlear implant users with tinnitus

*CART sound therapy* for tinnitus relief in Nucleus® cochlear implant users with tinnitus - CART study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46972
Enrollment
50
Registered
2018-11-19
Start date
2017-10-03
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

ringing of the ear Tinnitus

Interventions

CART sound therapy.
adult
cochlear implant
tinnitus

Sponsors

Cochlear AG, European Headquarters
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Self-reported tinnitus during standard cochlear implant use.

Exclusion criteria

Exclusion criteria: History of psychiatric disorders or depression (on investigator*s opinion).

Design outcomes

Primary

MeasureTime frame
The main study parameters are the change in VAS-scores (Visual Analog Scale) on tinnitus loudness and annoyance and the change in the score on the Tinnitus Functional Index (TFI) between baseline and intervention.

Secondary

MeasureTime frame
Secondary parameters are the ratings on the acceptability of CART sounds, (Serious) Adverse Event reporting and speech perception tests with CART on and off.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)