Status:
RECRUITING
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
Lead Sponsor:
Itamar-Medical, Israel
Conditions:
Sleep Disorder
Eligibility:
All Genders
12-99 years
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 wi...
Detailed Description
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. Additionall...
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.
Key Trial Info
Start Date :
September 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06093633
Start Date
September 19 2022
End Date
October 1 2025
Last Update
August 22 2025
Active Locations (3)
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1
Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
2
University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
Towson, Maryland, United States, 21286
3
Tel-Aviv Medical Center
Tel Aviv, Israel, 6423906