Clinical trial NCT06093633: A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
Official title: A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disorder
Keywords: WatchPAT
Polysomnography
ambulatory device
sleep apnea
apnea-hypopnea index
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with suspected sleep disorders or patients with comorbidities that increase the likelihood of central sleep apnea who are referred for a sleep study.

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 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.

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.

Primary outcomes:
measure: Apnea- Hypopnea Index (AHI)
timeFrame: one night of sleep
measure: Sleep Stages
timeFrame: one night of sleep
Secondary outcomes:
measure: Respiratory Disturbance Index (RDI)
timeFrame: one night of sleep
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Asthma and Allergy Center
state: Maryland
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
state: Maryland
city: Tel Aviv
country: Israel
facility: Tel-Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Rivi Tauman, Prof,
role: PRINCIPAL_INVESTIGATOR
References: