Recruiting

WP vs. PSG

Sponsor:

Itamar-Medical, Israel

Code:

NCT06093633

Conditions

Sleep Disorder

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06093633

Start date

Sep 19, 2022

Status verified date

Aug, 2025

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Apnea- Hypopnea Index (AHI) [ Time Frame: one night of sleep ]
  • Sleep Stages [ Time Frame: one night of sleep ]

Central Contacts and Locations

Central contacts

Ravit Roytman

00972545456819ravit.lusky@zoll.com

Locations

Johns Hopkins Bayview Asthma and Allergy Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Luu Pham, MD

410-550-2233luu.pham@jhmi.edu

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

Recruiting

Towson, Maryland, United States, 21286

Contacts

Alan Schwartz, MD

(410) 832-3400aschwar02@gmail.com

More Information

Sponsor

Itamar-Medical, Israel

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Itamar-Medical, Israel on 2025-08-22.