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NCT Number: NCT06093633

A Prospective Study to Evaluate the WP in Comparison to PSG 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.

Recruiting

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Key information

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel-Aviv Medical Center, Tel Aviv, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Apnea- Hypopnea Index (AHI)

    Time frame: one night of sleep

    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

  2. Sleep Stages

    Time frame: one night of sleep

    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.

Secondary outcomes

  1. Respiratory Disturbance Index (RDI)

    Time frame: one night of sleep

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ravit Roytman

CONTACT

[email protected]

00972545456819

Sponsors and collaborators

Lead sponsor

Itamar-Medical, Israel

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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