Trial document




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  DRKS00016123

Trial Description

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Title

Sleep stage mediated hemodynamic state modulation reflected by spectral variation of photoplethysmographic pulse volume curves

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

During standard sleep medicine investigation by polysomnography (PSG) the oxygen saturation is always monitored by pulse oximetry. Photoplethysmographic pulse volume curves (PVC) from the oximeter are investigated by fast fourier transformation (FFT) in order to identify frequency and signal intensity of the different wave components. By converting the signal intensity into colour codes the frequency traces of all wave components can be shown for all PVCs of a complete PSG recording in a frequency time graph. Results of a prelimnary study gave evidence for characteristic changes of the PVC spectrum in dependence on the sleep stage. Especially in the comparison of non-REM and REM (Rapid Eye Movement) sleep the signal intensity of the harmonics seem to vary from strong intensity during non-REM sleep to very low intensity during REM sleep. Another observation from the preliminary investigations was a systematic change in the PVC frequency spectrum in dependence on the type and intensity of different heart and vessel diseases. For a possible differentiation of these diseases from a normal variations in a PVC frequency spectrum the aim of this study is to collect baseline PVC frequency spectrum data from healthy subjects without heart or vessel diseases.

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Brief Summary in Scientific Language

From polysomnographic (PSG) recordings photoplethysmographic pulse volume curves (PVC) of the oximeters are investigated by fast fourier transformation. Wave components are characterized by frequency and signal intensity. By converting the signal intensity into colour codes the frequency traces of all wave components can be shown for all PVCs of a complete PSG recording in a frequency time graph (spectrum). Preliminary investigations have shown sleep stage dependent alterations of the PVC frequency spectrum, especially in comparison of non-REM and REM sleep. Furthermore characteristic changes were observed in different chronic heart and vessel diseases. In order to distinguish these from normal spectral variations the aim of this study is to collect baseline PVC frequency spectrum data from healthy subjects without heart or vessels diseases.

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Organizational Data

  •   DRKS00016123
  •   2018/12/17
  •   [---]*
  •   yes
  •   Approved
  •   93/18, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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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

  •   During diagnostic nighttime polysomnography in patients that are for the first time admitted to the sleep laboratory pulse volume curves (PVC) from the pulse oximeter are recorded. In order to determine the frequencies and signal intensities that contribute to the contour of the pulse wave shape fast fourier transformation (FFT) of the complete nighttime recording is done. Prelimnary investigations have shown that the PVC frequency spectrum varies by sleep stage, especially in transitions from non-REM to REM (Rapid Eye Movement) sleep and vice versa. Furthermore characteristic changes were observed in different chronic heart and vessel diseases. In order to distinguish these from normal spectral variations the aim of this study is to collect baseline PVC frequency spectrum data from healthy subjects without heart or vessel diseases. The subjects are identified by echocardiogram and NT-ProBNP (N-terminales pro brain natriuretic peptide) values. Normal values describe quantitatively for each sleep stage the intensity of the FFT-identified frequency maxima in the range of 0-10Hz by determining relative amplitude values of the highest frequency peak at the one-fold pulse frequency in comparison to the amplitudes of the harmonics.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

For each sleep stage for at least 10 samples of 32 seconds recording time the absolute values of signal intensity of each frequency peak of the FFT is determined in the range of 0-10Hz. Due to the fact that these absolute values are varying in dependence on perfusion at the oximeter site they are transformed into relative values. The sum of all amplitude maxima is set to 100% and each frequency peak is assigned by it relative contribution to 100%. For each sleep stage the homogeneity of the results of at least 10 samples is investigated by Bartlett test. When homogeneity within one sleep stage is confirmed the results for the different sleep stages are tested for significant differences (p<0.05) by analysis of variance (ANOVA). Primary outcome is reached when intra individual reproducibility of the results is confirmed that always homogeneity within one sleep stage occurs and the only differences are those in the comparison of sleep stages to each other.

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Secondary Outcome

The secondary outcome is reached if the observed differences between the results of the different sleep stages are interindividually comparable values by t-test (pairs) or ANOVA (multiple). If these values are different a possible systematic influence by age, gender or body-mass-index is investigated by factorial analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/12/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

normal electricity of the heart is confirmed and sinus rhythm of the cardiac cycles is observed

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Exclusion Criteria

- heart diseases and heart insufficiency are excluded
- vessel diseases are excluded

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Fachkrankenhaus Kloster Grafschaft GmbH
    • Mr.  Dr.  Jens  Kerl 
    • Annostr. 1
    • 57392  Schmallenberg
    • Germany
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    •   02972-7911703
    •   02972-7911709
    •   j.kerl at fkkg.de
    •   [---]*
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    • Fachkrankenhaus Kloster Grafschaft GmbH
    • Mr.  Dr.  Jens  Kerl 
    • Annostr. 1
    • 57392  Schmallenberg
    • Germany
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    •   02972-7911703
    •   02972-7911709
    •   j.kerl at fkkg.de
    •   [---]*
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    • Fachkrankenhaus Kloster Grafschaft GmbH
    • Mr.  Dr.  Jens  Kerl 
    • Annostr. 1
    • 57392  Schmallenberg
    • Germany
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    •   02972-7911703
    •   02972-7911709
    •   j.kerl at fkkg.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Fachkrankenhaus Kloster Grafschaft GmbH
    • Mr.  Dr.  Jens  Kerl 
    • Annostr. 1
    • 57392  Schmallenberg
    • Germany
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    •   02972-7911703
    •   02972-7911709
    •   j.kerl at fkkg.de
    •   [---]*
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Status

  •   Recruiting planned
  •   [---]*
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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.