Trial document




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  DRKS00003966

Trial Description

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Title

Investigations on the individual phenotype and genetic profile of sleep apnea syndrome

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Trial Acronym

SAGIC

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URL of the Trial

http://www.med.upenn.edu/sleepctr/SAGIC

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Brief Summary in Lay Language

We will enroll patients with sleep apnea using a standardized research protocol in order to find genetic determinants for sleep apnea. The research protocol consists of a sleep center investigation, assessment of sleepiness during daytime, chronotype testing, the anatomical characteristics of the upper airways, and blood pressure. Patients from all continents will be investigated and from all patients blood probes will be taken in order to check for common and different genetic characteristics. Alltogether several thousand patients will be collected over several years.

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Brief Summary in Scientific Language

Sleep apnea affects 2-4% of the population and is characterised by obstruction of the upper airway during sleep. These “breathing cessations” lead to reduced blood oxygen and daytime sleepiness with an increased risk for accidents. In addition, it affects the metabolism and cardiovascular system, leading to reduced life expectancy. These breathing cessations often are unnoticed by the patients themselves, so that respective co-morbidities can manifest. Although phenotypic markers of sleep apnea have been identified, there is only little knowledge about the etiology of sleep apnea. Therefore, diagnosis of sleep apnea is time consuming, cost intensive and requires polysomnographic examinations across several nights. Therapeutic interventions can only actively prevent obstruction of the upper airways, by wearing a special sleep mask (cPAP) or by upper airway surgery. To date, there is no clinical test available to identify people at risk to develop sleep apnea. The project proposed here, therefore, aims at establishing a comprehensive database of phenotypic and genotypic information about sleep apnea patients, to better understand the etiology of sleep apnea. For the first time in a study on sleep apnea, we will also evaluate the distribution of different chronotypes among sleep apnea patients, to elucidate the interplay with the circadian, internal clock. The results will strongly advance our understanding of the development and expression of sleep apnea – a win-win situation for both the individual and the health care system.

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Organizational Data

  •   DRKS00003966
  •   2013/03/15
  •   [---]*
  •   yes
  •   Approved
  •   EA1/245/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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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

  •   Sleep apnea patients are going to be investigated. The investigation consists of a cardiorespiratory polysomnography. In addition, saliva samples were taken for genotyping. Digital photos of the oral cavity and of the skull are taken in order to evaluate upper airway morphology. Questionnaires are collected.
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Characteristics

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

Genotyping of sleep apnea

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Secondary Outcome

What: The severity of sleep apnea determined by apnea / hypopnea index and oxygen desaturation index. How: Polysomnography, digital photographs of the upper airways, questionnaires. When: An examination of the Gentype will be done once the 6000 subjects were recruited.

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Countries of Recruitment

  •   Germany
  •   United States
  •   Iceland
  •   Australia
  •   Taiwan, Province of China
  •   Brazil
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/12/05
  •   4000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Suspected sleep apnea

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Exclusion Criteria

Non compliance with the study protocol. Other cardiovascular, neurological, mental disorders which are dominant compared to sleep apnea.

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Addresses

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    • Interdisziplinäres Schlafmedizinisches Zentrum Charité Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Thomas  Penzel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Interdisziplinäres Schlafmedizinisches Zentrum Charité Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Thomas  Penzel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Interdisziplinäres Schlafmedizinisches Zentrum Charité Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Thomas  Penzel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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* This entry means the parameter is not applicable or has not been set.