Actively Recruiting
A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Led by Itamar-Medical, Israel · Updated on 2025-08-22
600
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the WatchPAT (WP) device's ability to detect sleep disorders compared to the gold standard polysomnography (PSG) in patients suspected of sleep disorders. Participants include individuals referred for sleep studies or those with comorbidities related to central sleep apnea. The study is prospective and blinded, aiming to gather data on the WP device's performance during clinical sleep evaluations. Participants will spend one night in a clinical sleep laboratory where they will simultaneously wear the WP device with a finger probe and chest sensor while undergoing a full-night PSG recording with standard channels. The PSG data will be recorded and manually scored without access to WP data to maintain blinding, while the WP device data will be analyzed automatically. This design allows comparison between the WP device and PSG results. During the study night, demographic and medical information will be collected from participants or their medical charts. Researchers will assess the Apnea-Hypopnea Index (AHI) and sleep stages from one night of sleep as primary outcomes, with the Respiratory Disturbance Index (RDI) as a secondary outcome. The study involves a single overnight visit with no long-term follow-up, focusing on accurately measuring sleep disorder indicators through both methods.
CONDITIONS
Brief Title
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 99 years
- Ability to read, understand, and sign the informed consent form (or by parents if under 18)
- Suspected of having sleep disorders or with comorbidities relevant to central sleep apnea
You will not qualify if you...
- Having a permanent pacemaker: atrial pacing or VVI without sinus rhythm
- Finger deformity that prevents adequate use of the sensor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 night
Participants spend one night in a clinical sleep laboratory where they undergo full night polysomnography (PSG) and simultaneously wear the WatchPAT device for sleep disorder assessment.
1 overnight visit (in-person)
Trial Site Locations
Total: 3 locations
1
Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
2
University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
Towson, Maryland, United States, 21286
Actively Recruiting
3
Tel-Aviv Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
Research Team
R
Ravit Roytman
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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