Trial document





This trial has been registered retrospectively.
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  DRKS00009396

Trial Description

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Title

An objective method for calculating the subjective annoyance caused by snoring sounds

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Subjects assess different snoring and breath sounds on a visual analog scale (VAS) for level of annoyance. This psychometrics (subjective assessments) and psychoacoustics (objective psychometric parameters; loudness, roughness, sharpness and fluctuation strength) are correlated by a linear regression analysis. The quality of the resulting formula is checked, and additional validation is performed using subjective assessments by new subjects of new snoring and breath sounds. Receiver operating characteristic (ROC) analysis is used to scale the annoyance ranges obtained with the formula.

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Organizational Data

  •   DRKS00009396
  •   2015/09/25
  •   [---]*
  •   yes
  •   Approved
  •   11-101-0025, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   U1111-1174-8311 
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Health Condition or Problem studied

  •   RHONCHOPATHIE
  •   R06.5 -  Mouth breathing
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Interventions/Observational Groups

  •   Subjects assess different snoring and breath sounds on a visual analog scale (VAS) for level of annoyance. This psychometrics (subjective assessments) and psychoacoustics (objective psychometric parameters; loudness, roughness, sharpness and fluctuation strength) are correlated by a linear regression analysis. The quality of the resulting formula is checked, and additional validation is performed using subjective assessments by new subjects of new snoring and breath sounds.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Correlation of psychometrics (subjective assessments) and psychoacoustics (objective psychometric parameters; loudness, roughness, sharpness and fluctuation strength). Objective psychometric parameters of the sound sequences are determined using dBSONIC software. Developing and validating a snore score.

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Secondary Outcome

Annoyance of snoring (determined by the psychometrics; these are subjective assessments on color-, number- and description-coded analog scales)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/03/26
  •   105
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

A informed consent of subjects, subjects with normal hearing (self-reported, not tested objectively)

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Exclusion Criteria

no consent, impaired hearing subjects (self-reported, not tested objectively)

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Addresses

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    • HNO-Universitätsklinik Regensburg
    • Mr.  PD Dr. med.  Christian  Rohrmeier 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • HNO-Universitätsklinik Regensburg
    • Mr.  René  Fischer 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • HNO-Universitätsklinik Regensburg
    • Mr.  René  Fischer 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • HNO-Universitätsklinik Regensburg
    • Mr.  PD Dr. med.  Christian  Rohrmeier 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/24
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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.