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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093633
• Other study ID #: WP-001
• Status: Recruiting
• Start date: September 19, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: Itamar-Medical, Israel
• Contact: Ravit Roytman
• Phone: 00972545456819
• Email: ravit.lusky[@]zoll.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
Israel	Tel-Aviv Medical Center	Tel Aviv
United States	Johns Hopkins Bayview Asthma and Allergy Center	Baltimore	Maryland
United States	University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea- Hypopnea Index (AHI)	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	one night of sleep
Primary	Sleep Stages	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.	one night of sleep
Secondary	Respiratory Disturbance Index (RDI)	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	one night of sleep