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Studien zur FACEFORMER Therapie
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Wirkung der FaceFormer Therapie bei Schnarchen und Schlafapnoe

In einer kontrollierten Studie (Pilotstudie) soll der Erfolg der FaceFormer Therapie bei Patienten mit Schnarchen und Schlafapnoe beurteilt werden. Dabei wird für eine dreimonatige Phase eine tägliche Therapie von 4 Übungseinheiten gefordert. Eine Übungseinheit umfasst jeweils 20 Wiederholungen der Grundübung und 20 Wiederholungen mindestens einer Zugübung. Nach ca. 3 Wochen, wenn eine trainingsbedingte verbesserte Nasenatmung gespürt wird, wird der FaceFormer auch nachts angewendet. Ziel ist das Angewöhnen der Nasenatmung.

Untersuchungszeitraum

25.3.02 – 30.1.03

Untersuchungsintervalle

6 Untersuchungstermine
Eingangsuntersuchung, danach 4x nach jeweils 3 Wochen, 1x nach weiteren 3 Monaten
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Probanden

Bei Beginn der Untersuchung 38 Probanden. Ausgewertet wurden nur 30 Probanden, die an 6 Kontrollterminen teilgenommen und den Übungsverlauf auf einem Vordruck regelmäßig protokolliert hatten.

N = 30
Ausgewählte Patienten: Diagnostiziertes Schlafapnoesyndrom
RDI > 18. Geschlechtsunabhängig, 8 w, 22 m
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[av_heading heading=’Alter der Probanden’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-5pdji9y’][/av_heading]

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Lebensalter der Probanden
N = 30
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Alterswerte
N = 30
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[av_heading heading=’Body-Mass-Index (BMI)’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-hv0e06′][/av_heading]

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Der Body-Mass-Index wurde bei der Eingangsuntersuchung bestimmt.

N = 30
Max = 39
Min = 19
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Untersuchungsvorgehen

Es wurden Patienten ausgewählt, von denen polysomnographische Untersuchungsergebnisse aus Schlaflaboren oder aus ambulanten Untersuchungen vorlagen. Die Daten wurden als Ausgangswerte für die Untersuchung gewählt. Alle Diagnosen lagen nicht länger als 6 Monate zurück. Bei den Patienten war gewährleistet, dass sie während der FaceFormer Therapie keine anderen Behandlungen anwendeten. Einige Patienten, die mit NCPAP oder BIPAP versorgt waren, nutzten die Geräte aufgrund mangelnder Akzeptanz nicht oder nicht mehr. Keiner von den Teilnehmern hatte sich bisher einer Operation gegen Schnarchen unterzogen.

Bei den Kontrollterminen trugen die Patienten ihre Einschätzungen zu Veränderungen des Schlafes, Tagesmüdigkeit, Vigilanz und zu Auswirkungen auf die allgemeine Befindlichkeit in eine Bewertungsskala von 1-10 ein. 1 entsprach dabei der schlechtesten, 10 der besten Bewertung.

Bei allen Terminen wurden Lippenkraftmessung mit dem ISST-Myo-Bar-Meter durchgeführt und als verlaufsdiagnostische Daten notiert. Dabei wurde davon ausgegangen, dass mit verbesserter Lippenkraft die Wahrscheinlichkeit des Mundschlusses während der Schlafphasen erhöht wird und durch den nächtlichen Mundschluss eine Nasenatmung angewöhnt wird.

Nach 12 Wochen nahmen alle Patienten an einer ambulanten polysomnographischen Untersuchung teil. Diese wurden nach weiteren 3 Monaten (insgesamt von Therapiebeginn nach 6 Monaten) wiederholt. Die Ergebnisse wurden als Abschlussdaten für die Untersuchung verwendet.
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Nächtliche Schnarchepisoden

Vor der Therapie zeigte sich bei allen Probanden deutliche Schnarchepisoden.

Kein Schnarchen (Stufe 1)
vorher: 0 Probanden
nachher: 16 Probanden
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Anzahl nächtlicher Schnarchepisoden vor und nach der Therapie
N = 30
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Einteilung in 4 Stufen

N = 30
Wert 1 = keine
Wert 2 = leichte
Wert 3 = vermehrte
Wert 4 = deutlich vermehrte
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[av_heading heading=’Respiratory Disturbance Index (RDI) ‘ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-4hpc546′][/av_heading]

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RDI vor und nach Therapie

N = 30
RDI vor Therapie = 18-25
RDI nach Therapie = 1-14
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[av_heading heading=’RDI-Entwicklung’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-3sufhqe’][/av_heading]

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Entwicklung des RDI innerhalb von 12 Wochen

N = 30

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[av_heading heading=’Relative Entwicklung des RDI’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-3ixx4p2′][/av_heading]

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RDI-Entwicklung innerhalb von 12 Wochen in Prozent bezogen auf

N = 30
Durchschnittliche Besserung = 70,81%
Geringste Besserung = 50%
Größte Besserung = 88,89%
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[av_heading heading=’ Dauer der nächtlichen Atemaussetzer in Sekunden’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-aqkzra’][/av_heading]

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Atempausen in Sekunden

N = 30
vor Therapie = 8-48
nach Therapie = 1-14
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[av_heading heading=’Durchnittlicher Sauerstoffwert während der Schlafphase’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-2fza0me’][/av_heading]

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Durchschnittliche Sauerstoffversorgung
vor und nach Therapie

N = 30
vor Therapie = 71-99
nach Therapie = 89-99
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[av_heading heading=’Lippenkraftmessung mit ISST-Myo-Bar-Meter’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-29slwdi’][/av_heading]

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Lippenkraft vor und nach Therapie

N = 30
vor Therapie = 18-35 mBar
nach Therapie = 45-68 mBar
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Bei der Messung der Lippenkraft erreichte zu Beginn der Studie kein Teilnehmer den Min-Normwert von 36 mBar. Am Ende der Studie lagen alle deutlich darüber. Kein Teilnehmer lag unter 45 mBar.
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[av_heading heading=’Lippenkraftmessung über 12 Wochen’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-1nz90au’][/av_heading]

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Entwicklung der Lippenkraft über 12 Wochen

N = 30
Mittelwert = 102,93%
kleinste Steigerung = 41,18%
größte Steigerung = 172,22%
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Eigeneinschätzung der Probanden

N = 30
Bewertungsskala 1-10
schlechtester Wert = 1
bester Wert = 10
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[av_heading heading=’Institut für Spezielle Systemische Therapie’ tag=’h4′ link=” link_target=” style=’blockquote modern-quote’ size=” subheading_active=” subheading_size=” margin=” padding=’10’ color=” custom_font=” custom_class=” id=” admin_preview_bg=” av-desktop-hide=” av-medium-hide=” av-small-hide=” av-mini-hide=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-mg86di’][/av_heading]

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ISST Unna
Wasserstr. 25
D-59423 Unna

Email: buero@isst-unna.de
Tel.: +49-2303/86888
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Studie: FaceFormer® Therapie wirkt gegen Schnarchen und Schlafapnoe