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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02369705

Enrollment

200

Registered

2015-02-24

Start date

2015-06-30

Completion date

2016-06-30

Last updated

2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada, Germany, Israel, United States

Outcome results