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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

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).

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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.

Conditions

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Sleep-Disordered Breathing

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

WatchPAT 200 (TM)

Intervention Type 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.

Polysomnography

Intervention Type 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.

Diagnostic Device (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.

Group Type ACTIVE_COMPARATOR

WatchPAT 200 (TM)

Intervention Type 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.

Polysomnography

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No