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

Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities

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".

Study Overview

• Status: Completed
• Conditions: Sleep Disorders

Detailed Description

Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in the study. Subjects will be asked to sign an informed consent form and will be screened for inclusion exclusion criteria.

Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate pre-study electronic case report forms.

The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on the wrist.

The investigator will not have access to the WP200/WP200U data while scoring the PSG data. During the study recording, the WP200/WP200U data will be recorded inside the device, without being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done automatically without knowledge of the PSG scoring results.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3N 1X1
      • Centre for Sleep and Chronobiology
• Germany
  • Berlin, Germany, 10117
    • Charité-Universitätsmedizin
• Israel
  • Beer Sheva, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Health Care Campus
  • Tel-Aviv, Israel
    • Ichilov Medical Center
• United States
  • California
    • Los Angeles, California, United States, 95864
      • Kaiser Los Angeles
    • Los Angeles, California, United States
      • Kaiser Permanente Fontana
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose
  • Florida
    • Gainsville, Florida, United States
      • University of Florida
  • New York
    • Smithtown, New York, United States
      • Stony Brook medical center sleep lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with cardiac disorder, referred to the sleep lab for a night study, who consent to undergo an overnight sleep study in the clinical sleep laboratory.

Description

Inclusion Criteria:

• Age between17-90
• Subject is able to read understand and sign the informed consent form.
• Subject with diagnosed cardiac disorders and/or other comorbidity
• Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

Exclusion Criteria:

• Permanent pacemaker: atrial pacing or VVI without sinus rhythm
• Finger deformity that precludes adequate sensor appliance.
• Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG	calculation of the sensitivity, specificity, agreement and correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard" disorders for subjects with cardiac disorders and/or comorbidities, to the manual scoring of the PSG that serves as a "gold standard".	Within 1 year after data collection is complete.

Collaborators and Investigators

• Sponsor: Itamar-Medical, Israel
• Investigators: Principal Investigator: Thomas Penzel, Prof., Charite University, Berlin, Germany; Principal Investigator: Richard Berry, Prof., University of Florida

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: WP200/U-Cardio-001