A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Disorder. Basic parameters: 12 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Overview
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.
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. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.
Primary outcome measures
- Apnea- Hypopnea Index (AHI) [Time frame: one night of sleep]
- Sleep Stages [Time frame: one night of sleep]
Secondary outcome measures (1)
- Respiratory Disturbance Index (RDI) [Time frame: one night of sleep]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- Johns Hopkins Bayview Asthma and Allergy Center — Baltimore
- University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine — Towson
Israel · 1 center
- Tel-Aviv Medical Center — Tel Aviv
Identifiers
NCT: NCT06093633 · WP-001