RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-19
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06093633

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 12-99
  2. * 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
  3. * Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.
  1. * Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
  2. * Finger deformity that precludes adequate sensor appliance.

Contacts and Locations

Study Contact

Ravit Roytman
CONTACT
00972545456819
ravit.lusky@zoll.com

Principal Investigator

Rivi Tauman, Prof,
PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center

Study Locations (Sites)

Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, 21224
United States
University of Maryland St. Joseph Medical Group, Pulmonary Care & Sleep Medicine
Towson, Maryland, 21286
United States

Collaborators and Investigators

Sponsor: Itamar-Medical, Israel

  • Rivi Tauman, Prof,, PRINCIPAL_INVESTIGATOR, Tel Aviv Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-19
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2022-09-19
Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

  • WatchPAT
  • Polysomnography
  • ambulatory device
  • sleep apnea
  • apnea-hypopnea index

Additional Relevant MeSH Terms

  • Sleep Disorder