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

Primary Purpose

Sleep-Disordered Breathing

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WatchPAT 200 (TM)
Polysomnography
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep-Disordered Breathing focused on measuring Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Polysomnography

Diagnostic Device (WatchPAT 200 (TM))

Arm Description

The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.

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.

Outcomes

Primary Outcome Measures

Apnea-Hypopnea-Index (AHI)
Index is stated per hour (/h)

Secondary Outcome Measures

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

Full Information

First Posted
April 20, 2016
Last Updated
March 15, 2017
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
Collaborators
Itamar-Medical, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02760680
Brief Title
Validation of the Peripheral Arterial Tone to Detect Sleep-disordered Breathing in Patients With Chronic Heart Failure
Official Title
Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia
Collaborators
Itamar-Medical, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-Disordered Breathing
Keywords
Chronic Heart Failure, Sleep-Disordered Breathing, Peripheral Arterial Tone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysomnography
Arm Type
Placebo Comparator
Arm Description
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
Arm Title
Diagnostic Device (WatchPAT 200 (TM))
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
WatchPAT 200 (TM)
Other Intervention Name(s)
PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel
Intervention Description
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
Other
Intervention Name(s)
Polysomnography
Intervention Description
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea-Index (AHI)
Description
Index is stated per hour (/h)
Time Frame
one night of sleep
Secondary Outcome Measure Information:
Title
Sleep: Time in bed
Description
stated in minutes (min)
Time Frame
one night of sleep
Title
Sleep: Total sleep time
Description
stated in minutes (min)
Time Frame
one night of sleep
Title
Sleep: Sleep latency
Description
stated in minutes (min)
Time Frame
one night of sleep
Title
Sleep: Rapid-Eye-Movement (REM) sleep latency
Description
stated in minutes (min)
Time Frame
one night of sleep
Title
Sleep: latency to S3
Description
stated in minutes (min)
Time Frame
one night of sleep
Title
Sleep: Wake
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: S1 stadium/total sleep time
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: S2 stadium/total sleep time
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: S3 stadium/total sleep time
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: REM sleep/total sleep time
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: Sleep Efficiency
Description
amount of sleep, stated in percent (%)
Time Frame
one night of sleep
Title
Sleep: Number of Wakes
Description
stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Oxygen-Desaturation-Index (ODI)
Description
Index is stated per hour (/h)
Time Frame
one night of sleep
Title
Respiratory Parameters: longest Apnea
Description
stated in seconds (s)
Time Frame
one night of sleep
Title
Respiratory Parameters: longest Hypopnea
Description
stated in seconds (s)
Time Frame
one night of sleep
Title
Respiratory Parameters: Obstructive Apnea
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Central Apnea
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Mixed Apnea
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Obstructive Hypopnea
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Central Hypopnea
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Hypopnea total
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Apnea + Hypopnea total
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Desaturations
Description
Index is stated per hour (/h), stated as number
Time Frame
one night of sleep
Title
Respiratory Parameters: Mean Oxygen Saturation (sO2)
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Respiratory Parameters: Minimum Oxygen Saturation (sO2)
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Respiratory Parameters: Maximum Oxygen Saturation (sO2)
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Respiratory Parameters: Mean of Desaturations Nadirs
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Respiratory Parameters: Mean of Desaturations
Description
stated in percent (%)
Time Frame
one night of sleep
Title
Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%
Description
stated in percent (%), stated in minutes (min)
Time Frame
one night of sleep
Title
Respiratory Parameters: Respiratory-Disturbance-Index (RDI)
Description
Index is stated per hour (/h)
Time Frame
one night of sleep
Title
Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA)
Description
Comparison of all Parameters added above
Time Frame
one night of sleep

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bitter, MD
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Florian Schindhelm
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
City
Bad Oeynhausen
State/Province
North Rhine - Westphalia
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12628865
Citation
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.
Results Reference
background
Links:
URL
http://www.hdz-nrw.de
Description
Official website of Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
URL
http://www.itamar-medical.com
Description
Official website of Itamar Medical Ltd.

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

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