Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters
August 25, 2015 updated by: Itamar-Medical, Israel
Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing
The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies.
The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population will include adolescence subjects, age 12-17, referred to the clinical sleep laboratory for an overnight sleep study
Description
Inclusion Criteria:
- Age between 12-17
- Subjects with a legal guardian that is able to read understand and sign the informed consent form
- Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab
Exclusion Criteria:
- Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
- Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
PSG and WatchPAT200 in subjects age12-17
Adolescents refered to a sleep lab for sleep lab for full night PSG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
Time Frame: 1 night
|
1 night
|
|
correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
Time Frame: 1 night
|
1 night
|
|
Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
Time Frame: 1 night
|
1 night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
February 17, 2015
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimate)
March 4, 2015
Study Record Updates
Last Update Posted (Estimate)
August 27, 2015
Last Update Submitted That Met QC Criteria
August 25, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WP200/U-adolescence- 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.