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Completed

NCT Number: NCT02760680

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

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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Key information

Conditions

Sleep-Disordered Breathing Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WatchPAT 200 (TM)

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.

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

Polysomnography

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.

Primary outcomes

  1. Apnea-Hypopnea-Index (AHI)

    Time frame: one night of sleep

    Index is stated per hour (/h)

Secondary outcomes

  1. Sleep: Time in bed

    Time frame: one night of sleep

    stated in minutes (min)

  2. Sleep: Total sleep time

    Time frame: one night of sleep

    stated in minutes (min)

  3. Sleep: Sleep latency

    Time frame: one night of sleep

    stated in minutes (min)

  4. Sleep: Rapid-Eye-Movement (REM) sleep latency

    Time frame: one night of sleep

    stated in minutes (min)

  5. Sleep: latency to S3

    Time frame: one night of sleep

    stated in minutes (min)

  6. Sleep: Wake

    Time frame: one night of sleep

    stated in percent (%)

  7. Sleep: S1 stadium/total sleep time

    Time frame: one night of sleep

    stated in percent (%)

  8. Sleep: S2 stadium/total sleep time

    Time frame: one night of sleep

    stated in percent (%)

  9. Sleep: S3 stadium/total sleep time

    Time frame: one night of sleep

    stated in percent (%)

  10. Sleep: REM sleep/total sleep time

    Time frame: one night of sleep

    stated in percent (%)

  11. Sleep: Sleep Efficiency

    Time frame: one night of sleep

    amount of sleep, stated in percent (%)

  12. Sleep: Number of Wakes

    Time frame: one night of sleep

    stated as number

  13. Respiratory Parameters: Oxygen-Desaturation-Index (ODI)

    Time frame: one night of sleep

    Index is stated per hour (/h)

  14. Respiratory Parameters: longest Apnea

    Time frame: one night of sleep

    stated in seconds (s)

  15. Respiratory Parameters: longest Hypopnea

    Time frame: one night of sleep

    stated in seconds (s)

  16. Respiratory Parameters: Obstructive Apnea

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  17. Respiratory Parameters: Central Apnea

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  18. Respiratory Parameters: Mixed Apnea

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  19. Respiratory Parameters: Obstructive Hypopnea

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  20. Respiratory Parameters: Central Hypopnea

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  21. Respiratory Parameters: Hypopnea total

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  22. Respiratory Parameters: Apnea + Hypopnea total

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  23. Respiratory Parameters: Desaturations

    Time frame: one night of sleep

    Index is stated per hour (/h), stated as number

  24. Respiratory Parameters: Mean Oxygen Saturation (sO2)

    Time frame: one night of sleep

    stated in percent (%)

  25. Respiratory Parameters: Minimum Oxygen Saturation (sO2)

    Time frame: one night of sleep

    stated in percent (%)

  26. Respiratory Parameters: Maximum Oxygen Saturation (sO2)

    Time frame: one night of sleep

    stated in percent (%)

  27. Respiratory Parameters: Mean of Desaturations Nadirs

    Time frame: one night of sleep

    stated in percent (%)

  28. Respiratory Parameters: Mean of Desaturations

    Time frame: one night of sleep

    stated in percent (%)

  29. Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%

    Time frame: one night of sleep

    stated in percent (%), stated in minutes (min)

  30. Respiratory Parameters: Respiratory-Disturbance-Index (RDI)

    Time frame: one night of sleep

    Index is stated per hour (/h)

  31. 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

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • Itamar-Medical, Israel

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 4, 2016
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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