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

Sponsor
Itamar-Medical, Israel (Industry)
Overall Status
Completed
CT.gov ID
NCT02369705
Collaborator
(none)
200
Enrollment
10
Locations
12
Duration (Months)
20
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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".

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities
    Study Start Date :
    Jun 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG [Within 1 year after data collection is complete.]

      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".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Los Angeles Los Angeles California United States 95864
    2 Kaiser Permanente Fontana Los Angeles California United States
    3 Kaiser Permanente San Jose San Jose California United States 95119
    4 University of Florida Gainsville Florida United States
    5 Stony Brook medical center sleep lab Smithtown New York United States
    6 Centre for sleep and Chronobiology Toronto Ontario Canada M3N 1X1
    7 Charité-Universitätsmedizin Berlin Germany 10117
    8 Soroka Medical Center Beer Sheva Israel
    9 Rambam Medical Health Care Campus Haifa Israel
    10 Ichilov Medical Center Tel-Aviv Israel

    Sponsors and Collaborators

    • Itamar-Medical, Israel

    Investigators

    • Principal Investigator: Thomas Penzel, Prof., Charite University, Berlin, Germany
    • Principal Investigator: Richard Berry, Prof., University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Itamar-Medical, Israel
    ClinicalTrials.gov Identifier:
    NCT02369705
    Other Study ID Numbers:
    • WP200/U-Cardio-001
    First Posted:
    Feb 24, 2015
    Last Update Posted:
    Jul 15, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Sleep Wake Disorders

    Study Results

    No Results Posted as of Jul 15, 2016