Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure
- Conditions
- Sleep-Disordered Breathing
- Interventions
- Device: WatchPAT 200 (TM)Other: Polysomnography
- Registration Number
- NCT02760680
- Lead Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- reduced left ventricular ejection fraction (LVEF) < 45 %
- indication for a polysomnography
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Polysomnography Polysomnography The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. Polysomnography 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. Diagnostic Device (WatchPAT 200 (TM)) Polysomnography 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. Diagnostic Device (WatchPAT 200 (TM)) WatchPAT 200 (TM) 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.
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea-Index (AHI) one night of sleep Index is stated per hour (/h)
- Secondary Outcome Measures
Name Time Method Respiratory Parameters: Central Apnea one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Mixed Apnea one night of sleep Index is stated per hour (/h), stated as number
Sleep: Sleep Efficiency one night of sleep amount of sleep, stated in percent (%)
Sleep: Number of Wakes one night of sleep stated as number
Respiratory Parameters: Oxygen-Desaturation-Index (ODI) one night of sleep Index is stated per hour (/h)
Respiratory Parameters: longest Apnea one night of sleep stated in seconds (s)
Respiratory Parameters: longest Hypopnea one night of sleep stated in seconds (s)
Respiratory Parameters: Obstructive Apnea one night of sleep Index is stated per hour (/h), stated as number
Sleep: Total sleep time one night of sleep stated in minutes (min)
Sleep: Sleep latency one night of sleep stated in minutes (min)
Sleep: Rapid-Eye-Movement (REM) sleep latency one night of sleep stated in minutes (min)
Sleep: Time in bed one night of sleep stated in minutes (min)
Sleep: latency to S3 one night of sleep stated in minutes (min)
Sleep: Wake one night of sleep stated in percent (%)
Sleep: S1 stadium/total sleep time one night of sleep stated in percent (%)
Sleep: S2 stadium/total sleep time one night of sleep stated in percent (%)
Sleep: S3 stadium/total sleep time one night of sleep stated in percent (%)
Sleep: REM sleep/total sleep time one night of sleep stated in percent (%)
Respiratory Parameters: Obstructive Hypopnea one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Central Hypopnea one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Hypopnea total one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Mean of Desaturations Nadirs one night of sleep stated in percent (%)
Respiratory Parameters: Mean of Desaturations one night of sleep stated in percent (%)
Respiratory Parameters: Mean Oxygen Saturation (sO2) one night of sleep stated in percent (%)
Respiratory Parameters: Minimum Oxygen Saturation (sO2) one night of sleep stated in percent (%)
Respiratory Parameters: Maximum Oxygen Saturation (sO2) one night of sleep stated in percent (%)
Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90% one night of sleep stated in percent (%), stated in minutes (min)
Respiratory Parameters: Apnea + Hypopnea total one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Desaturations one night of sleep Index is stated per hour (/h), stated as number
Respiratory Parameters: Respiratory-Disturbance-Index (RDI) one night of sleep Index is stated per hour (/h)
Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA) one night of sleep Comparison of all Parameters added above
Trial Locations
- Locations (1)
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
🇩🇪Bad Oeynhausen, North Rhine - Westphalia, Germany