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| Name | Class |
|---|---|
| Itamar-Medical, Israel | INDUSTRY |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polysomnography | Placebo Comparator | The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. |
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| Diagnostic Device (WatchPAT 200 (TM)) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WatchPAT 200 (TM) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea-Index (AHI) | Index is stated per hour (/h) | one night of sleep |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Bitter, MD | Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | Study Director |
| Florian Schindhelm | Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12628865 | Background | Bar A, Pillar G, Dvir I, Sheffy J, Schnall RP, Lavie P. Evaluation of a portable device based on peripheral arterial tone for unattended home sleep studies. Chest. 2003 Mar;123(3):695-703. doi: 10.1378/chest.123.3.695. |
| Label | URL |
|---|---|
| Official website of Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany | View source |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
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| Polysomnography | Other | The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines. |
|
| 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 |
| Official website of Itamar Medical Ltd. | View source |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |