Sleep
Conditions
Keywords
diagnosing sleep
Brief summary
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.
Interventions
None listed
Sponsors
Itamar-Medical, Israel
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| 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 | 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 | 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 | 1 night |
Outcome results
None listed