Trial document




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  DRKS00003448

Trial Description

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Title

Development of pulmonary adaptations in breathhold diver beginners

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In previous studies pulmonary adaptations in elite breathhold divers have been shown such as high lung volume and a reduced respiratory drive to elevated CO2 concentrations. The breathing gas CO2 is a coproduct in metabolic generation of energy and is eliminated by respiratory air. The blood level of CO2 controls the respiratory drive in healthy humans. Elite breath hold diver perform a special maneuver to prolongate maximal breathhold duration. This maneuver is characterized by a certain breathing technique ("lung packing, glossopharyngeal breathin") which allows the apnoe diver fill in more air into the lung than normally cointained.
Breathhold diving beginners are supposed to present with a normal respiratory drive and a normal lung function when starting breathold diving. Till now it's unknown in which time course the adaptations mentioned above develop.
This project aims to investigate breath hold diver beginners during a period of three years of regular training (at least 4 times per month). Every 4 months there should be lung function measurements to determine pulmonary adaptations. During this period a training and diving protocol is kept.

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Brief Summary in Scientific Language

In recent studies certain pulmonary adaptations have been shown to take place in breathhold divers such as a highly normal lung volume and a reduced respiratory drive to elevated CO2 blood levels compared to healthy subjects and scuba divers.
It is postulated that subjects interested in breathhold diving present with normal respiratory drive and lung function when starting their training. Till now it is unknown in what period of time the above mentioned adaptations take place.
A longitudinal monitoring during 3 years of regular training (at least 4 times per month) of adaptations in CO2 dependent respiratory drive is the primary endpoint of the study. Secondary endpoints are alterations of lung function parameters and the development of sufficient ability of glossopharyngeal insufflation (GI).
The target sample size of 11 breathhold diver beginners are supposed to be included when successfully passed through a diving medicine examination without pathological findings according to GTÜM recommendations of 2010.
Exclusion criteria are respiratory diseases, cardiac or neuromuscular or HNO co-morbidities as well as more than 80 dives in scuba diving.
Performed tests are standard investigations in pneumologic diagnostic. Measurements at rest and spirometric measurement of GI take place in dry conditions at the Muskellabor, department of pneumology.
The following parameters will be detected:
• Respiratory drive at rest, at rebreathing of 6% and 9% CO2 in ambient air; blood gas analysis
• bodyplethysmography
• maximal static apnea; blood gas analysis after maximal static apnea
• Maximal volume added by glossopharyngeal insufflation

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Organizational Data

  •   DRKS00003448
  •   2012/02/07
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  •   yes
  •   Approved
  •   407/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1126-5863 
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Health Condition or Problem studied

  •   Healthy volunteers: Sports scientific research on breath hold divers
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Interventions/Observational Groups

  •   Breath hold divers, at least 4x/month apnea training, < 80 scuba dives/year
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Characteristics

  •   Interventional
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  •   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

statistical significant alteration in central respiratory drive at rebreathing of 6% and 9& CO2 in comparison to baseline; spirometric measurements via CO2-rebreathing method; assessment every 4 months over a period of 3 years

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Secondary Outcome

lung function parameters in bodyplethysmography, increase in lung volume after lung packing in spirometry; assessment every 4 months over a period of 3 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/02/15
  •   11
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

breathhold diver beginner, diving medicine examination without pathological findings

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Exclusion Criteria

respiratory deseases, cardial or neuromuscular or HNO comorbidities, more than 80 dives in scuba diving

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Addresses

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    • Uniklinik Freiburg, Abteilung Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Pneumologie
    • Mr.  Dr. med.  Tobias  Scholz 
    • Killianstr.5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Pneumologie
    • Mr.  Dr. med.  Tobias  Scholz 
    • Killianstr.5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg, Abteilung Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr.5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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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.