Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00018819

Trial Description

start of 1:1-Block title

Title

Evaluation and Validation of the Digital-Triplet-Test for normal Hearing poeple and CI recipients

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

Trial Acronym

[---]*

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

The aim is to determine the feasibility of the digit-triple-test (DTT) for normal hearing people and cochlear implant recipients. These include the reliability of the test results or the trainig effect.
Due to the simple speech material and the intuitive use of the user interface a differentiation of the test results is to be achieved for patients, who show soil or ceiling effects in other leaching tests.

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

Brief Summary in Scientific Language

The aim of the study is the validation of the digit triplet test (DTT) in background noise for normal Hearing people, i.e. the data collection of standard values ​​for the discrimination in noise and the associated discrimination function as well as the examination of the test-retest accuracy and the training effect (description of its properties according to DIN ISO 8253-3: 2008). In addition, the use of the DTT to determine the speech intelligibility in noise in cochlear implant (CI) recipients. In addition to the feasibility of the CI recipients itself, it should also be checked whether this test provides comparable results as established tests (Oldenburg sentence test).

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?

[---]*

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

  •   DRKS00018819
  •   2019/12/18
  •   [---]*
  •   yes
  •   Approved
  •   Eth-40/18, Ethik-Kommission der Ärztekammer Berlin
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

  •   Z96.8 -  Presence of other specified functional implants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   CI recipients: Freiburg monosyllable in quiet (65 dB), DTT (SNR adaptive and fixed)
  •   people with normal Hearing: pure-tone audiometry (air conducted), DTT (SNR adaptive and fixed)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

-Calculation of the discrimination function

-Calculation of the perceptual equivalence of digits by specifying the mean 95%

-Confidence intervals between the speech intelligibility thresholds of the digits (SVS_Ziffer)

-Calculation of the reproducibility of the results (average test-retest reliability): DIN EN ISO 8253-3 specifically requires the indication of the mean test-retest reliability in percentage points. This reliability is the outcome of squared difference between the measurement results (adaptive measurements) of test and retest - averaged over the subjects. From this value the square root is calculated and multiplied by 2. The mean reliability test against retest) is considered to be the mean 95% confidence interval indicated by the subjects.

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

Secondary Outcome

-average test duration (in minutes) -Training effects (number of adaptive measurements that are necessary until the deviation of the measurement results for the SVS is <1dB)
-Compared to established language tests, i.e. the determined speech intelligibility threshold (SVS_DTT) from the reference curve of the DTT is compared with the reference values ​​of the Oldenburg sentence test (OLSA)

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

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/08/23
  •   40
  •   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

german mothertongue

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

Exclusion Criteria

under 18 years

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Vivantes Klinikum Friedrichshain - Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Landsberger Allee 49
    • 10249  Berlin
    • 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
    • Vivantes Klinikum Friedrichshain - Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr.-Ing.  Alexander  Müller 
    • Landsberger Allee 49
    • 10249  Berlin
    • 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
    • Vivantes Klinikum Friedrichshain - Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr.-Ing.  Alexander  Müller 
    • Landsberger Allee 49
    • 10249  Berlin
    • 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
    • Vivantes Klinikum FriedrichshainKlinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Cochlear Deutschland GmbH & Co. KG
    • 30625  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
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.