NCT06093633 A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
| NCT ID | NCT06093633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Itamar-Medical, Israel |
| Condition | Sleep Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-09-19 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2022-09-19 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Rivi Tauman, Prof,
PRINCIPAL INVESTIGATOR
Tel Aviv Medical Center
Frequently Asked Questions
Who can join the NCT06093633 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 99 Years, studying Sleep Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06093633 currently recruiting?
Yes, NCT06093633 is actively recruiting participants. Contact the research team at ravit.lusky@zoll.com for enrollment information.
Where is the NCT06093633 trial being conducted?
This trial is being conducted at Baltimore, United States, Towson, United States, Tel Aviv, Israel.
Who is sponsoring the NCT06093633 clinical trial?
NCT06093633 is sponsored by Itamar-Medical, Israel. The principal investigator is Rivi Tauman, Prof, at Tel Aviv Medical Center. The trial plans to enroll 600 participants.