Trial document




drksid header

  DRKS00011195

Trial Description

start of 1:1-Block title

Title

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

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

[---]*

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

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).

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

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

  •   G47.3 -  Sleep apnoea
end of 1:N-Block indications
start of 1:N-Block interventions

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

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

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

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).

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

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

Recruitment

  •   Actual
  •   2016/11/02
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Signed consent
• Suspected sleep-related breathing disorder

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

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

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • 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
    • Hochschule Ulm
    • Mr.  Christoph  Kalkbrenner 
    • Albert-Einstein-Allee 55
    • 89081  Ulm
    • 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
    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • 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
    • Universitätsklinikum Ulm
    • Ms.  Dr. med.  Cornelia  Kropf-Sanchen 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • 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 complete
  •   2018/04/02
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.