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

March 15, 2017 updated by: Thomas Bitter, Heart and Diabetes Center North-Rhine Westfalia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine - Westphalia
      • Bad Oeynhausen, North Rhine - Westphalia, Germany, 32545
        • Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
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.
Other Names:
  • PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel
Other: 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.
Active Comparator: 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.
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.
Other Names:
  • PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Collaborators

Itamar-Medical, Israel

Investigators

  • Principal Investigator: Florian Schindhelm, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZNRW-KA_005_TB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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