Sleep-Disordered Breathing Clinical Trial
Official title:
Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz
A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).
Patients with chronic heart failure (CHF), reduced left ventricular ejection fraction
(LVEF<45%) and predicted sleep-disordered breathing (SDB) receive a diagnostic device
(WatchPAT 200 (TM)) and polysomnography (PSG) simultaneously during on night in a hospital
sleep lab.
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is
the measurement of the peripheral arterial tone (PAT) via a plethysmographic based
finger-mounted probe. It can measure the level of sympathetic activation of the autonomic
nervous system. Pulse rate, oxygen saturation and snoring/body position levels are
calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw
data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims
that the WatchPAT 200 (TM) can detect sleep events and SDB.
The PSG is scored by sleep lab physicians/technicians blinded to the zzzPAT (TM)-software
results using current American Academy of Sleep Medicine (AASM) guidelines.
Both results will be compared and the results of the device will be validated and evaluated
against the results of the "Gold Standard" polysomnography.
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