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Validation of Sleepware G3 Autoscoring Algorithm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564472
Recruitment Status : Withdrawn (De-identified PSGs were to be scored by a vendor prior to being sent to the sponsor. Issues occurred with vendor and no PSGs were analyzed by the sponsor.)
First Posted : March 27, 2012
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Brief Summary:
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.

Condition or disease Intervention/treatment
Polysomnography Scoring Other: PSG Scoring

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of Sleepware G3 Autoscoring Algorithm

Group/Cohort Intervention/treatment
PSG Scoring
Retrospective, de-identified PSG studies will be collected and scored by registered polysomnogrpahy technicians. The manually scored studies will be compared to the automatic scoring performed by the new Sleepware Software G3 Autoscoring Algorithm.
Other: PSG Scoring
No participants will be enrolled and no interventions, besides PSG scoring will be utilized.




Primary Outcome Measures :
  1. PSG Scoring Validity [ Time Frame: 6 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any retrospective, de-identified adult polysomnogram collected using American Society of Sleep Medicine (AASM) criteria.
Criteria

Inclusion Criteria:

  • AASM Compliant PSG studies

Exclusion Criteria:

  • NA
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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01564472    
Other Study ID Numbers: Dx-1152-SWGVAL-SS
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019