A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder

Detailed Description

Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. 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 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 with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Ravit Roytman; Phone Number: 00972545456819; Email: ravit.lusky@zoll.com

Study Locations

• Israel
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel-Aviv Medical Center
    • Contact: Rivi Tauman, MD; Phone Number: 00972524262025; Email: tauman@tlvmc.gov.il
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Asthma and Allergy Center
      • Contact: Luu Pham, MD; Phone Number: 410-550-2233; Email: luu.pham@jhmi.edu
    • Towson, Maryland, United States, 21286
      • Recruiting
      • University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
      • Contact: Alan Schwartz, MD; Phone Number: 2218 410-832-3400; Email: aschwar02@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with suspected sleep disorders or patients with comorbidities that increase the likelihood of central sleep apnea who are referred for a sleep study.

Description

Inclusion Criteria:

• Age between 12-99
• Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory
• Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.

Exclusion Criteria:

• Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
• Finger deformity that precludes adequate sensor appliance.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea- Hypopnea Index (AHI)	Compares the results of the automatically scored AHI of the WP to the manually scored AHI of the PSG (Gold Standard). AHI is the average number of apnea and hypopnea events per hour of sleep	one night of sleep
Sleep Stages	Compares the results of the automatically scored sleep stages of the WP to the manually scored sleep stages of the PSG (Gold Standard). Stages are light sleep, deep sleep, REM or Wake.	one night of sleep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Disturbance Index (RDI)	Compares the results of the automatically scored RDI of the WP to the manually scored RDI of the PSG (Gold Standard). RDI is the average number of respiratory events per hour of sleep	one night of sleep

Collaborators and Investigators

• Sponsor: Itamar-Medical, Israel
• Investigators: Principal Investigator: Rivi Tauman, Prof,, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Polysomnography; sleep apnea; apnea-hypopnea index; ambulatory device; WatchPAT
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: WP-001

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No