Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00022973

Trial Description

start of 1:1-Block title

Title

Kalmeda Tinnitus Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

TKS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

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

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00022973
  •   2020/10/09
  •   [---]*
  •   no
  •   Approved
  •   2020026, Ethikkommission der Ärztekammer Nordrhein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   H93.1 -  Tinnitus
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/08/07
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Chronic tinnitus longer than 3 months

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

psychological diseases

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • mynoise GmbH
    • Mr.  Christof  Schifferings 
    • Landshuterstraße 1
    • 47249  Duisburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • HNO-Praxis
    • Mr.  Dr.med.  Roland Piers Uso  Walter 
    • Mülheimerstraße 70
    • 47057  Duisburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • HNO-Praxis
    • Mr.  Dr. med.  Roland Piers Uso  Walter 
    • Mülheimerstraße 70
    • 47057  Duisburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • mynoise GmbH
    • Mr.  Christof  Schifferings 
    • Landshuterstraße 1
    • 47249  Duisburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
  •   [---]*
  •   [---]*
  •   187
  •   187
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.