Sleep-Disordered Breathing
Conditions
Keywords
Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone
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.
Interventions
DEVICEWatchPAT 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.
OTHERPolysomnography
The PSG is known as the Gold Standard for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
Sponsors
Itamar-Medical, Israel
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea-Index (AHI) | one night of sleep | Index is stated per hour (/h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Respiratory Parameters: Desaturations | one night of sleep | Index is stated per hour (/h), stated as number |
| 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: Apnea + Hypopnea total | one night of sleep | Index is stated per hour (/h), stated as number |
| Respiratory Parameters: Oxygen-Desaturation-Index (ODI) | one night of sleep | Index is stated per hour (/h) |
| Sleep: Time in bed | one night of sleep | stated in minutes (min) |
| 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: latency to S3 | one night of sleep | stated in minutes (min) |
| Respiratory Parameters: longest Apnea | one night of sleep | stated in seconds (s) |
| 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 (%) |
| 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: 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: 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: Time Oxygen Saturation (TsO2) < 90% | one night of sleep | stated in percent (%), stated in minutes (min) |
| 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 |
| Sleep: Wake | one night of sleep | stated in percent (%) |
Countries
Germany
Outcome results
None listed