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

Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369705
• Other study ID #: WP200/U-Cardio-001
• Status: Completed
• Phase: N/A
• First received: February 8, 2015
• Last updated: July 14, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2016
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Institutional Review BoardGermany: Ethics CommissionIsrael: Ethics Commission
• Study type: Observational

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Locations

Country	Name	City	State
Canada	Centre for sleep and Chronobiology	Toronto	Ontario
Germany	Charité-Universitätsmedizin	Berlin
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medical Health Care Campus	Haifa
Israel	Ichilov Medical Center	Tel-Aviv
United States	University of Florida	Gainsville	Florida
United States	Kaiser Los Angeles	Los Angeles	California
United States	Kaiser Permanente Fontana	Los Angeles	California
United States	Kaiser Permanente San Jose	San Jose	California
United States	Stony Brook medical center sleep lab	Smithtown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No