A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Itamar-Medical, Israel
- Study ID
- NCT06093633
- Status
- Recruiting
Conditions
- Sleep Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 99 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Sep 19, 2022
- Status verified
- Aug 2025
- Primary completion
- Oct 1, 2025
- Completion
- Oct 1, 2025
Study Design
- Enrollment
- 600 participants (estimated)
Primary Outcome Measure
Apnea- Hypopnea Index (AHI) [ Time Frame: one night of sleep ]
Central Contacts
- Ravit Roytman00972545456819
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Bayview Asthma and Allergy Center | Baltimore | Maryland | 21224 | |
| University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine | Towson | Maryland | 21286 |
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