Trial document




drksid header

  DRKS00005952

Trial Description

start of 1:1-Block title

Title

Regional ventilation and zentral oxygenation in singing and playing wind instrument- A study with professional singers and wind intrument players

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

Singers, Voice teachers and therapists generally agree that respiratory behavior is important to voice function. The coordination of breathing muscles, larynx and the resulting subglottic pressure, that is needed for singing phonation, are central points that have to be trained in in the voice pedagogy. Nevertheless concepts of breathing strategies for singing phonation differ extreme and physiologic backgrounds are insufficient understood. Also the effect of the breathing patters on the brain oxygenation (the oxygen content) is unknown. The same applies to breathing patters in wind instrument players.

The aim of this study was therefore to analyze the breathing patterns of professional singers and wind instrument players and to study their relationship to central oxygenation.

To study the regional ventilation the electro impedance tomography (EIT) is used a technique that analyzes regional information of pulmonary air content due to beathing maneuvers with the help of impedance measurements. The central oxygenation is analyzed using a cerebral oximeter with the help of near infrared spectroscopy. Furthermore the perfusion of a carotid artery will be monitored with Doppler sonography to provide information about the affarent perfusion of the brain while singing oder playing.
To provide comparable examination conditions additionally an electroglottographic wavegram will provide information about the laryngeal mechanisms.

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

Brief Summary in Scientific Language

Singers, Voice teachers and therapists generally agree that respiratory behavior is important to voice function. The coordination of breathing muscles, larynx and the resulting subglottic pressure are central points that have to be trained in in the voice pedagogy but concepts of breathing strategies for singing phonation differ extreme and physiologic backgrounds are insufficient understood. Also the effect of the breathing patters on the brain oxygenation is unknown. The same applies to breathing patters in wind instrument players.
The aim of this study was therefore to analyze the breathing patterns of professional singers and wind instrument players and to study their relationship to central oxygenation.
To study the regional ventilation the electro impedance tomography (PulmoVista 500, Dräger) is used a technique that analyzes regional information of pulmonary air content due to beathing maneuvers with the help of impedance measurements. The central oxygenation is analyzed using a cerebral oximeter (INVOS™ 5100C ‚Ä®Cerebral / Somatic Oximeter, Covidien) with the help of near infrared spectroscopy. Furthermore the perfusion of a carotid artery will be monitored with Doppler sonography.
To provide comparable examination conditions additionally an electroglottographic wavegram (Laryngograph micoProcessors) will provide information about the laryngeal mechanisms.

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

  •   DRKS00005952
  •   2014/03/03
  •   [---]*
  •   yes
  •   Approved
  •   82/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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

  •   Beathing in singing and wind instrument playing
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   professional singer, different Fach (Alto, Soprano, Tenor, Bass), using EIT (Electrical impedance tomography), EGG (Electroglottography) and cerebral oximeter, combined with Doppler sonography of carotid artery
  •   wind instrument players, comparison of brass and woodwind instrument players, High pressure systems (like trumpet players or oboists) and low pressure systems like flute players, wind instrument players that perform permanent breathing; using of EIT, cerebral oximeter and Doppler sonography of the carotid artery.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Regional ventilation (via EIT; PulmoVista 500; Dräger), while singing/ playing and zentral oxygenation while singing/ playing and in 2 Minutes after playing (using INVOS™ 5100C ‚Ä®Cerebral / Somatic Oximeter)

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

Secondary Outcome

speed of blood flow in carotid artery (using Doppler sonography of the carotid artery) while singing/ playing and in 2 Minutes after playing,

contact quotient of vocal folds, fundamental frequency, pertubation (using EGG, Laryngograph micoProcessor) while singing

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

  •   Planned
  •   2014/03/17
  •   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
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

professional singers of different fach, professional wind instrument players, informed consent

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

Exclusion Criteria

age <18 Years, Pregnancy, pulmunary desease, pacemaker, defibrillator, or other implanted electronic device, patch allergy, no informed consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • 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
    • Insitut für Musikermedizin und HNO Klinik Freiburg
    • Ms.  Dr.  Louisa  Traser 
    • Breisacherstr. 60
    • 79106  Freiburg
    • 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
    • Insitut für Musikermedizin und HNO Klinik Freiburg
    • Ms.  Dr.  Louisa  Traser 
    • Breisacherstr. 60
    • 79106  Freiburg
    • 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
    • Insitut für MusikermedizinUniversitätsklinik Freiburg
    • Mr.  Prof. Dr.  Bernhard  Richter 
    • Breisacherstr. 60
    • 79106  Freiburg
    • 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 planned
  •   [---]*
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.