MedTrace Logo

Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects

NCT02369705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2016-07-15

No results posted yet for this study

Summary

Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner.

The PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine.

The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG's manual scoring which serves as a "Gold Standard".

Conditions

  • Sleep Disorders

Sponsors & Collaborators

  • Itamar-Medical, Israel

    lead INDUSTRY

Principal Investigators

  • Thomas Penzel, Prof. · Charite University, Berlin, Germany

  • Richard Berry, Prof. · University of Florida

Eligibility

Min Age
17 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States
  • Canada
  • Germany
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02369705 on ClinicalTrials.gov