Trial document



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  DRKS00011195

Trial Description

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Title

Validation of a new method for ambulant diagnosis of sleep related breathing disorders using body sound.

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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

Validation of a new monitoring system based on body sound in subjects with suspected sleep apnea syndrome using apnea-hypopnea-index (AHI) determined by polysomnography (PSG).

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011195
  •   2016/10/18
  •   [---]*
  •   yes
  •   Approved
  •   288/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   G47.3 -  Sleep apnoea
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Interventions/Observational Groups

  •   During their regular diagnosis night in the sleep laboratory, participating subjects carry the new sleep monitor parallel to the polysomnography. The sleep monitor consists of two components. The actual electronics are housed in a small case that is attached to the chest strap of the polysomnography. From this housing, a cable leads to a microphone that is fixed at the neck using an adhesive membrane. Over the night the device records breathing sounds, heart sounds as well as a movement profile and sends these wirelessly to a laptop. There the recordings are stored. Finally, the apnea-hypopnea-index is calculated by an automated algorithm using the recorded body sound.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of this study is to verify if the new sleep monitor (body sound) is equivalent to polysomnography in the diagnosis of sleep-related respiratory disorders.

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Secondary Outcome

The secondary aim of this study is to verify if the new sleep monitor can be used reliably and without any complications. Another secondary aim of this study is to examine if there are other correlations between the data of the new sleep monitor (e.g. heart sounds and respiratory sounds) and PSG (e.g. ECG and respiratory flow).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/11/02
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Signed consent
• Suspected sleep-related breathing disorder

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Exclusion Criteria

• known allergies or intolerances with patches
• serious illnesses or diseases that affect the participation of the subjects in the study or make them impossible
• Lack of willingness to participate in the study

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Addresses

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    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Hochschule Ulm
    • Mr.  Christoph  Kalkbrenner 
    • Albert-Einstein-Allee 55
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/02
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Trial Publications, Results and other Documents

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