A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

Sponsor

Itamar-Medical, Israel (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06093633

Collaborator

(none)

600

Enrollment

Locations

27.4

Anticipated Duration (Months)

200

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders

Actual Study Start Date :

Sep 19, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Apnea- Hypopnea Index (AHI) [one night of sleep]
Compares the results of the automatically scored AHI of the WP to the manually scored AHI of the PSG (Gold Standard). AHI is the average number of apnea and hypopnea events per hour of sleep
Sleep Stages [one night of sleep]
Compares the results of the automatically scored sleep stages of the WP to the manually scored sleep stages of the PSG (Gold Standard). Stages are light sleep, deep sleep, REM or Wake.

Secondary Outcome Measures

Respiratory Disturbance Index (RDI) [one night of sleep]
Compares the results of the automatically scored RDI of the WP to the manually scored RDI of the PSG (Gold Standard). RDI is the average number of respiratory events per hour of sleep

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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