Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
has not begun yet.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSG and WatchPAT200 in subjects age12-17 | Adolescents refered to a sleep lab for sleep lab for full night PSG |
Not provided
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population will include adolescence subjects, age 12-17, referred to the clinical sleep laboratory for an overnight sleep study
Not provided
Not provided
Not provided
Not provided