Trial document





This trial has been registered retrospectively.
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  DRKS00000549

Trial Description

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Title

The surgical treatment of obstructive sleep apnea (OSA) using tonsillectomy with uvulapalatopharyngoplasty - A clinical randomized study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aims of the study is to investigate the effect of tonsillectomy with uvulapalatopharyngoplasty (TE-UPPP) for the surgical treatment of the obstructive sleep apnea at a high level of evidence in patients who are intolerant and not adherant to conservative treatment including CPAP. Although the TE-UPPP is a widespread surgical technique there are still open questions regarding the effectiveness of the treatment.
To investigate this effectiveness a randomized controlled trial will be performed. A baseline sleep examination using Polysomnography (PSG) is undertaken and subjective measures are recorded using questionnaires. One group of obstructive sleep apnea (OSA) patients is then receiving TE-UPPP and one group is used as a non-treated control. After 3 month an additional PSG is performed and the questionnaires are answered again.

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Brief Summary in Scientific Language

For therapy of the obstructive sleep apnea (OSA) syndrome there are many treatment options including conservative and surgical approaches. A possible surgical approach is tonsillectomy in combination with Uvulapalatopharyngoplasty (TE-UPPP). This classic intervention is used since 1981 in various modification to treat OSA. Excess mucosa at the soft palate and the uvula is resected and the whole soft palate is tightened. Although this form of therapy is used for approx. 30 years, only a limited number of prospective, randomized trials concerning the outcome of this therapy are available. Therefore the effectiveness can't be definitely assessed. The aim of this study is to assess the effectiveness of the TE-UPPP in a prospective, randomized study.
At first a baseline sleep examination using Polysomnography (PSG) is performed. Additional parameters are assessed with questionnaires. One group of OSA patients is then receiving TE-UPPP and the other is used as a non-treated control. After 3 month another PSG is made and the questionnaires are answered again.

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Organizational Data

  •   DRKS00000549
  •   2010/09/08
  •   [---]*
  •   yes
  •   Approved
  •   2009-325N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   G47.31 -  [generalization G47.3: Sleep apnoea]
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Interventions/Observational Groups

  •   Surgical Group:

    Visit 0:
    1 Night Polysomnography
    Checking of the inclusion and exclusion criterias
    Information about the study and informed consent
    Registration of daytime sleepiness using a questionnaire
    Registration of daytime sleepiness using pupillometry
    Registration of various other questionnaires
    Taking of blood sample
    Registration of heart rate and blood pressure
    Randomization

    Visit 1:
    (up to 1 Month after Visit 0)
    TE-UPPP

    Visit 2:
    (about 3 Month after Visit 1)
    Registration of daytime sleepiness using a questionnaire
    Registration of daytime sleepiness using pupillometry
    Registration of various other questionnaires
    Taking of blood sample
    Registration of heart rate and blood pressure
    1 Night Polysomnography
  •   Non-Surgical Group:

    Visit 0:
    1 Night Polysomnography
    Checking of the inclusion and exclusion criterias
    Information about the study and informed consent
    Registration of daytime sleepiness using a questionnaire
    Registration of daytime sleepiness using pupillometry
    Registration of various other questionnaires
    Taking of blood sample
    Registration of heart rate and blood pressure
    Randomization

    Visit 2:
    (3 Month after Visit 0)
    Registration of daytime sleepiness using a questionnaire
    Registration of daytime sleepiness using pupillometry
    Registration of various other questionnaires
    Taking of blood sample
    Registration of heart rate and blood pressure
    1 Night Polysomnography

    The exact time of the TE-UPPP is set by the patient after completion of the study
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

respiratory parameter of polysomnography (AI, AHI, RDI, ODI)
quality of sleep parameter in polysomnography (Arousal-Index, Sleep-Efficency, Sleep-Stages)

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Secondary Outcome

Registration of daytime sleepiness using a questionnaire
Registration of daytime sleepiness using pupillometry
Registration of effects of the intervention and quality of life using questionnaires
Overall happiness with the intervention
Snoring score using a visual analog scale
Cardiovascular risk parameters (HR, BP, CRP and many more)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2010/02/03
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

manifest obstructive sleep apnea syndrome confirmed using polysomnography
relevant tonsillary hyperplasia
CPAP (continuous positive airway pressure) Intolerance

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Exclusion Criteria

Body-Mass-Index > 32 kg/m2
Relevant comorbiditys (American Society for Anesthesiology (ASA): ASA > III)
Other relevant sites of obstruction seen in clinical examination
Deformities of facial bone seen in clinical examination

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HNO-Univ.-Klinik Mannheim
    • Mr.  Prof. Dr.  Boris A.  Stuck 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • HNO-Univ.-Klinik Mannheim
    • Mr.  Priv.-Doz. Dr. med  J. Ulrich  Sommer 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • HNO-Univ.-Klinik Mannheim
    • Mr.  Priv.-Doz. Dr. med.  J. Ulrich  Sommer 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/12
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Trial Publications, Results and other Documents

  •   Sommer JU, Heiser C, Gahleitner C, Herr RM, Hörmann K, Maurer JT, Stuck BA: Tonsillectomy with uvulopalatopharyngoplasty in obstructive sleep apnea—a two-center randomized controlled trial. Dtsch Arztebl Int 2016; 113: 1–8. DOI: 10.3238/arztebl.2016.0001
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* This entry means the parameter is not applicable or has not been set.