Trial document




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  DRKS00008968

Trial Description

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Title

Effect of repeated dives in salt and fresh water on function of the tympanic membrane and its anatomical changes.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The popularity of recreational diving is rising. After several multi-level dives the divers often complain about painful equalization problems and / or about ear pain.
There are several local and systemic treatment options for so called "diver´s ear". However, the actual anatomical, physiological and functional changes of the tympanic membrane and fo the middle ear are not clear.
The aim of this trial is to characterize the anatomical changes of the tympanic membrane after multi-level dives and to correlate them with the divers´complains and the tympanic membrane function. The trial is planned with a group of divers, who have planned multi-level salt-water dives, as well as with divers in fresh water

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Brief Summary in Scientific Language

The popularity of recreational diving is rising. After several multi-level dives the divers often complain about painful equalization problems and / or about ear pain.
There are several local and systemic treatment options for so called "diver´s ear". However, the actual anatomical, physiological and functional changes of the tympanic membrane and of the middle ear are not clear.
The aim of this trial is to characterize the anatomical changes of the tympanic membrane after multi-level dives and to correlate them with the divers´complains and the tympanic membrane function, which is measured by tympanometry. The trial is planned with a group of divers, who have planned multi-level salt-water dives, as well as with divers in fresh water

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Organizational Data

  •   DRKS00008968
  •   2015/07/28
  •   [---]*
  •   yes
  •   Approved
  •   14-118, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Anatomical changes of tympanic membrane and the middle ear ventilation
  •   H69.8 -  Other specified disorders of Eustachian tube
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Interventions/Observational Groups

  •   The otoskopic examination and tympanometry are performed after salt-water dives.
    The dives are not performed for the study, the examiner is accompanying the divers
  •   The otoskopic examination and tympanometry are performed after fresh-water dives.
    The dives are not performed for the study, the examiner is accompanying the divers
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The anatomical and physiological changes of the tympanic membrane
- Otoskopic examinations (TEED-classification) prior to the 1. dive every day and after every dive

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Secondary Outcome

The tympanometric changes (equalization, compliance of the tympanic membrane) (without and after Valsalva). THe measurement is done before the 1st dive every day and after every dive.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/28
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Signed informed concent
The participant is planning to dive only in the saltwater (Sea)
The participant is planning to dive only in the fresh water (Lake)
The participant is 18years old or older

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Exclusion Criteria

Diving 12h prior to the trial
Diving not allowed for health reasons
Participation in this trial denied by the participant

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Addresses

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    • HNO Uniklinik Köln
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • HNO Uniklinik Köln
    • Ms.  PD Dr. med.  Maria  Grosheva 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • HNO-Uniklinik Köln
    • Ms.  PD Dr. med.  Maria  Grosheva 
    • Kerpenerstr. 63
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • HNO Uniklinik Köln
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/01
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Trial Publications, Results and other Documents

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