Clinical trial NCT02760680: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Keywords: Chronic Heart Failure
Sleep-Disordered Breathing
Peripheral Arterial Tone
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
Collaborators: name: Itamar-Medical, Israel
First posted: 2016-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Apnea-Hypopnea-Index (AHI)
timeFrame: one night of sleep
Secondary outcomes:
measure: Sleep: Time in bed
timeFrame: one night of sleep
measure: Sleep: Total sleep time
timeFrame: one night of sleep
measure: Sleep: Sleep latency
timeFrame: one night of sleep
measure: Sleep: Rapid-Eye-Movement (REM) sleep latency
timeFrame: one night of sleep
measure: Sleep: latency to S3
timeFrame: one night of sleep
measure: Sleep: Wake
timeFrame: one night of sleep
measure: Sleep: S1 stadium/total sleep time
timeFrame: one night of sleep
measure: Sleep: S2 stadium/total sleep time
timeFrame: one night of sleep
measure: Sleep: S3 stadium/total sleep time
timeFrame: one night of sleep
measure: Sleep: REM sleep/total sleep time
timeFrame: one night of sleep
measure: Sleep: Sleep Efficiency
timeFrame: one night of sleep
measure: Sleep: Number of Wakes
timeFrame: one night of sleep
measure: Respiratory Parameters: Oxygen-Desaturation-Index (ODI)
timeFrame: one night of sleep
measure: Respiratory Parameters: longest Apnea
timeFrame: one night of sleep
measure: Respiratory Parameters: longest Hypopnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Obstructive Apnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Central Apnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Mixed Apnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Obstructive Hypopnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Central Hypopnea
timeFrame: one night of sleep
measure: Respiratory Parameters: Hypopnea total
timeFrame: one night of sleep
measure: Respiratory Parameters: Apnea + Hypopnea total
timeFrame: one night of sleep
measure: Respiratory Parameters: Desaturations
timeFrame: one night of sleep
measure: Respiratory Parameters: Mean Oxygen Saturation (sO2)
timeFrame: one night of sleep
measure: Respiratory Parameters: Minimum Oxygen Saturation (sO2)
timeFrame: one night of sleep
measure: Respiratory Parameters: Maximum Oxygen Saturation (sO2)
timeFrame: one night of sleep
measure: Respiratory Parameters: Mean of Desaturations Nadirs
timeFrame: one night of sleep
measure: Respiratory Parameters: Mean of Desaturations
timeFrame: one night of sleep
measure: Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%
timeFrame: one night of sleep
measure: Respiratory Parameters: Respiratory-Disturbance-Index (RDI)
timeFrame: one night of sleep
measure: Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA)
timeFrame: one night of sleep
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen
state: North Rhine - Westphalia
Study officials:
affiliation: Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
name: Thomas Bitter, MD
role: STUDY_DIRECTOR
affiliation: Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany
name: Florian Schindhelm
role: PRINCIPAL_INVESTIGATOR
References:
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.