Trial document




This trial has been registered retrospectively.
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  DRKS00022973

Trial Description

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Title

Kalmeda Tinnitus Study

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Trial Acronym

TKS

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URL of the Trial

http://www.hno-praxis-duisburg.de/tinnitusstudie

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Brief Summary in Lay Language

The Kalmeda Tinnitus App offers cognitive behavioural therapy based on the Zurich Resource Model as well as acceptance and commitment therapy for patients with chronic tinnitus. The Kalmeda Tinnitus App is already approved as a medical device in Germany and has been available in the App and Playstore since the beginning of 2019. The Kalmeda Tinnitus Study aims to prove the improvement of the tinnitus burden and thus a positive supply effect by using the Kalmeda Tinnitus App. In addition, further effects of the use of the Kalmeda Tinnitus App on the self-efficacy, the stress experience as well as the tendency to depression are to be evaluated.

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Brief Summary in Scientific Language

In Germany, there are still no definitive guidelines for the evaluation of digital therapy procedures. The study design is therefore based on the recommendations of the National Institute for Health and Care Excellence in accordance with the "Evidence Standard Framework for Digital Health Technologies" of March 2019. According to this framework, the Kalmeda Tinnitus App can be classified in group 3a. Based on these recommendations, the evaluation design includes a combination of longitudinal and comparative group studies. There is an intervention group that starts treatment without any delay and a control group that starts the same treatment after a three-month waiting period. In the meantime, the waiting group receives information material about the tinnitus. The assignment of the patients to the intervention vs. control group is carried out by a computer-based randomisation procedure, which is assigned to an external provider in order to exclude influences.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00022973
  •   2020/10/09
  •   [---]*
  •   no
  •   Approved
  •   2020026, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H93.1 -  Tinnitus
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Interventions/Observational Groups

  •   The intervention group uses the Kalmeda Tinnitus App immediately.
  •   The control group uses the Kalmeda tinnitus app after a 3 month waiting period and receives general information about tinnitus.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome variable of the study is the total score of the tinnitus questionnaire by Göbel and Hiller. It is primarily used to assess the effectiveness of Kalmeda. The primary endpoint is defined as the tinnitus burden after three months.

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Secondary Outcome

As secondary endpoints, the respective changes in tinnitus burden, depression tendency, stress experience and self-efficacy after 12 months (control group) or 9 months (intervention group) are selected.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/08/07
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Chronic tinnitus longer than 3 months

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Exclusion Criteria

psychological diseases

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Addresses

  • start of 1:1-Block address primary-sponsor
    • mynoise GmbH
    • Mr.  Christof  Schifferings 
    • Landshuterstraße 1
    • 47249  Duisburg
    • Germany
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    • HNO-Praxis
    • Mr.  Dr.med.  Roland Piers Uso  Walter 
    • Mülheimerstraße 70
    • 47057  Duisburg
    • Germany
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    • HNO-Praxis
    • Mr.  Dr. med.  Roland Piers Uso  Walter 
    • Mülheimerstraße 70
    • 47057  Duisburg
    • Germany
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Sources of Monetary or Material Support

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    • mynoise GmbH
    • Mr.  Christof  Schifferings 
    • Landshuterstraße 1
    • 47249  Duisburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
  •   [---]*
  •   [---]*
  •   187
  •   187
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.