Kalmeda Tinnitus Study
Organizational Data
- DRKS-ID:
- DRKS00022973
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-10-09
- Last update in DRKS:
- 2022-10-06
- Registration type:
- Retrospective
Acronym/abbreviation of the study
TKS
URL of the study
http://www.hno-praxis-duisburg.de/tinnitusstudie
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.
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.
Health condition or problem studied
- ICD10:
- H93.1 - Tinnitus
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- The intervention group uses the Kalmeda Tinnitus App immediately.
- Arm 2:
- The control group uses the Kalmeda tinnitus app after a 3 month waiting period and receives general information about tinnitus.
Endpoints
- 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.
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Doctor's practice Duisburg
Recruitment period and number of participants
- Planned study start date:
- 2020-10-21
- Actual study start date:
- 2020-08-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-03-09
- Target Sample Size:
- 150
- Final Sample Size:
- 187
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Chronic tinnitus longer than 3 months
Exclusion Criteria
psychological diseases
Addresses
Primary Sponsor
- Address:
- mynoise GmbHChristof SchifferingsLandshuterstraße 147249 DuisburgGermany
- Telephone:
- 01727985464
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kalmeda.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- HNO-PraxisDr.med. Roland Piers Uso WalterMülheimerstraße 7047057 DuisburgGermany
- Telephone:
- 01788381852
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.hno-praxis-duisburg.de
Contact for Public Queries
- Address:
- HNO-PraxisDr. med. Roland Piers Uso WalterMülheimerstraße 7047057 DuisburgGermany
- Telephone:
- 0203355310
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.hno-praxis-duisburg.de
Principal Investigator
- Address:
- HNO-PraxisDr.med. Roland Piers Uso WalterMülheimerstraße 7047057 DuisburgGermany
- Telephone:
- 01788381852
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.hno-praxis-duisburg.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- mynoise GmbHLandshuterstraße 147249 DuisburgGermany
- Telephone:
- 01727985464
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kalmeda.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-01-24
- Ethics committee number:
- 2020026
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-05-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Prüfprotokoll
- Zwischenergebnisse der Kalmeda Tinnitus-Studie
- Abschlussbericht
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry