Evaluating a new device for detecting sleep disorders compared to traditional methods
A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Itamar-Medical, Israel · NCT06093633
This study is testing a new device called WatchPAT to see if it can detect sleep disorders as well as traditional sleep tests do.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | Itamar-Medical, Israel (industry) |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT06093633 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the WatchPAT device in detecting sleep disorders by comparing its results with those obtained from polysomnography (PSG). Participants suspected of having sleep disorders will wear the WatchPAT device alongside a full night PSG recording in a clinical sleep lab. Data will be collected on patient demographics and medical history, and the PSG will be scored manually while the WatchPAT analysis will be conducted automatically. The study seeks to determine the effectiveness of the WatchPAT device in diagnosing sleep disorders.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12-99 who are suspected of having sleep disorders or have comorbidities related to central sleep apnea.
Not a fit: Patients with permanent pacemakers or finger deformities that prevent proper sensor application may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for diagnosing sleep disorders.
How similar studies have performed: Other studies have shown promise in using similar ambulatory devices for sleep disorder detection, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins Bayview Asthma and Allergy Center — Baltimore, Maryland, United States (RECRUITING)
- University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine — Towson, Maryland, United States (RECRUITING)
- Tel-Aviv Medical Center — Tel Aviv, Israel (RECRUITING)
Study contacts
- Principal investigator: Rivi Tauman, Prof, — Tel Aviv Medical Center
- Study coordinator: Ravit Roytman
- Email: ravit.lusky@zoll.com
- Phone: 00972545456819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Disorder, WatchPAT, Polysomnography, ambulatory device, sleep apnea, apnea-hypopnea index