Clinical trial NCT02369705: Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
Official title: Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2015-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG
timeFrame: Within 1 year after data collection is complete.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Los Angeles
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Fontana
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Smithtown
country: United States
facility: Stony Brook medical center sleep lab
state: New York
city: Toronto
country: Canada
facility: Centre for sleep and Chronobiology
state: Ontario
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Health Care Campus
city: Tel-Aviv
country: Israel
facility: Ichilov Medical Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Thomas Penzel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Richard Berry, Prof.
role: PRINCIPAL_INVESTIGATOR
References: