Polysomnography Scoring Clinical Trial
Official title:
Validation of Sleepware G3 Autoscoring Algorithm
| NCT number | NCT01564472 |
| Other study ID # | Dx-1152-SWGVAL-SS |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated |
| Verified date | January 2019 |
| Source | Philips Respironics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: - AASM Compliant PSG studies Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Philips Respironics |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PSG Scoring Validity | The objective of this study is to validate the ability of the Sleepware G3 polysomnography software platform to correctly identify and score sleep related events. Specifically, the study will compare Sleepware autoscoring of respiratory events, sleep staging, leg movements, micro-arousals and desaturations, among possible others events, to manual scoring by two registered polysomnographic technologists (RPSGT). | 6 months |