Evaluating the WP Device for Sleep Disorders

This study is looking at how well a new device, called WP, can detect sleep disorders compared to a standard sleep study (PSG). If you are between 12 and 99 years old and are suspected of having a sleep disorder, or have other health issues related to central sleep apnea, you might be able to join. You would spend one night in a sleep lab wearing both the WP device and the standard PSG equipment. Researchers will compare the results from both to see how accurately the WP device measures things like your Apnea-Hypopnea Index (AHI), which counts breathing pauses during sleep, and your sleep stages. The study aims to enroll 600 participants, but its current status is unclear.

Study design
This is an observational study where researchers are comparing a new device to a standard test. It is a blinded study, meaning the people scoring the standard sleep study won't know the results from the new device. The study plans to include 600 participants.
What's involved
You would spend one night in a clinical sleep laboratory. During this night, you would wear both the WP device and standard PSG equipment.
Compensation
Not stated in the trial record.
Follow-up
Your sleep will be measured for one night during the study.

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NCT06093633

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

Recruiting
Not specifiedAges 12–99Observational
Itamar-Medical, Israel
~600 participants
Updated 2025-08-22 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apnea- Hypopnea Index (AHI)
Measured over one night of sleep
+1 more outcome measured
Sleep Disorder
3 sites across 2 states
Maryland2
Israel1
  • Rivi Tauman, Prof, · PRINCIPAL_INVESTIGATOR · Tel Aviv Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
Finger deformity that precludes adequate sensor appliance.
  • Apnea- Hypopnea Index (AHI)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

  • Sleep Stagesone 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.