Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz

Conditions
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Sleep-Disordered Breathing

Intervention / Treatment
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* Device: WatchPAT 200 (TM)
* Other: Polysomnography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Polysomnography<br>The PSG is known as the Gold Standard for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. | Device: WatchPAT 200 (TM)<br>* 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.<br>* Other names: PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel;Other: Polysomnography<br>* The PSG is known as the Gold Standard for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.<br>|
| Active Comparator: Diagnostic Device (WatchPAT 200 (TM))<br>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. | Device: WatchPAT 200 (TM)<br>* 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.<br>* Other names: PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel;Other: Polysomnography<br>* The PSG is known as the Gold Standard for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea-Index (AHI) | Index is stated per hour (/h) | one night of sleep | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep: Time in bed | stated in minutes (min) | one night of sleep | 
| Sleep: Total sleep time | stated in minutes (min) | one night of sleep | 
| Sleep: Sleep latency | stated in minutes (min) | one night of sleep | 
| Sleep: Rapid-Eye-Movement (REM) sleep latency | stated in minutes (min) | one night of sleep | 
| Sleep: latency to S3 | stated in minutes (min) | one night of sleep | 
| Sleep: Wake | stated in percent (%) | one night of sleep | 
| Sleep: S1 stadium/total sleep time | stated in percent (%) | one night of sleep | 
| Sleep: S2 stadium/total sleep time | stated in percent (%) | one night of sleep | 
| Sleep: S3 stadium/total sleep time | stated in percent (%) | one night of sleep | 
| Sleep: REM sleep/total sleep time | stated in percent (%) | one night of sleep | 
| Sleep: Sleep Efficiency | amount of sleep, stated in percent (%) | one night of sleep | 
| Sleep: Number of Wakes | stated as number | one night of sleep | 
| Respiratory Parameters: Oxygen-Desaturation-Index (ODI) | Index is stated per hour (/h) | one night of sleep | 
| Respiratory Parameters: longest Apnea | stated in seconds (s) | one night of sleep | 
| Respiratory Parameters: longest Hypopnea | stated in seconds (s) | one night of sleep | 
| Respiratory Parameters: Obstructive Apnea | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Central Apnea | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Mixed Apnea | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Obstructive Hypopnea | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Central Hypopnea | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Hypopnea total | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Apnea + Hypopnea total | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Desaturations | Index is stated per hour (/h), stated as number | one night of sleep | 
| Respiratory Parameters: Mean Oxygen Saturation (sO2) | stated in percent (%) | one night of sleep | 
| Respiratory Parameters: Minimum Oxygen Saturation (sO2) | stated in percent (%) | one night of sleep | 
| Respiratory Parameters: Maximum Oxygen Saturation (sO2) | stated in percent (%) | one night of sleep | 
| Respiratory Parameters: Mean of Desaturations Nadirs | stated in percent (%) | one night of sleep | 
| Respiratory Parameters: Mean of Desaturations | stated in percent (%) | one night of sleep | 
| Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90% | stated in percent (%), stated in minutes (min) | one night of sleep | 
| Respiratory Parameters: Respiratory-Disturbance-Index (RDI) | Index is stated per hour (/h) | one night of sleep | 
| Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA) | Comparison of all Parameters added above | one night of sleep | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone