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

NCT02369705 | Completed

• 1 other identifier: WP200/U-Cardio-001
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 10

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".

Conditions

Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (10)

Kaiser Los Angeles

Los Angeles, California, 95864, United States

Location

Kaiser Permanente Fontana

Los Angeles, California, United States

Location

Kaiser Permanente San Jose

San Jose, California, 95119, United States

Location

University of Florida

Gainsville, Florida, United States

Location

Stony Brook medical center sleep lab

Smithtown, New York, United States

Location

Centre for sleep and Chronobiology

Toronto, Ontario, M3N 1X1, Canada

Location

Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Health Care Campus

Haifa, Israel

Location

Ichilov Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Thomas Penzel, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Richard Berry, Prof.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: February 24, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-04

Locations

US (5); DE (1); CA (1); IL (3)