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

Sleep-Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760680
• Other study ID #: HDZNRW-KA_005_TB
• Status: Completed
• Phase: N/A
• First received: April 20, 2016
• Last updated: March 15, 2017
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration
• Sleep-Disordered Breathing

Intervention

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:
• 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.

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen	Bad Oeynhausen	North Rhine - Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia	Itamar-Medical, Israel

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   Official website of Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
•   Official website of Itamar Medical Ltd.