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

NCT06093633 | Recruiting

• 1 other identifier: WP-001
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Sleep Disorder

Keywords

WatchPAT; Polysomnography; ambulatory device; sleep apnea; apnea-hypopnea index

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Respiratory Disturbance Index (RDI)

  one night of sleep

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (3)

Johns Hopkins Bayview Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

RECRUITING

University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine

Towson, Maryland, 21286, United States

RECRUITING

Tel-Aviv Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Rivi Tauman, Prof,

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravit Roytman

CONTACT

00972545456819; ravit.lusky@zoll.com

Study Design

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

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 23, 2023
• Study Start: September 19, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)