Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure
Sleep-Disordered Breathing
About this trial
This is an interventional diagnostic trial for Sleep-Disordered Breathing focused on measuring Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone
Eligibility Criteria
Inclusion Criteria:
- reduced left ventricular ejection fraction (LVEF) < 45 %
- indication for a polysomnography
Exclusion Criteria:
- allergies against the device or parts of the device
- psychogenic or neurological disorders which do not allow a sufficient patient compliance
- osteogenetic disorders which do not allow a painless investigation
- pregnancy
Sites / Locations
- Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Polysomnography
Diagnostic Device (WatchPAT 200 (TM))
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
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.