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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Recruitment Status : Withdrawn (De-identified PSGs were to be scored by a vendor prior to being sent to the sponsor.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

Tracking Information
First Submitted Date March 20, 2012
First Posted Date March 27, 2012
Last Update Posted Date January 8, 2019
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 23, 2012)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Sleepware G3 Autoscoring Algorithm
Official Title Validation of Sleepware G3 Autoscoring Algorithm
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any retrospective, de-identified adult polysomnogram collected using American Society of Sleep Medicine (AASM) criteria.
Condition Polysomnography Scoring
Intervention Other: PSG Scoring
No participants will be enrolled and no interventions, besides PSG scoring will be utilized.
Study Groups/Cohorts 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.
Intervention: Other: PSG Scoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 4, 2019)
0
Original Estimated Enrollment
 (submitted: March 23, 2012)
100
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • AASM Compliant PSG studies

Exclusion Criteria:

  • NA
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01564472
Other Study ID Numbers Dx-1152-SWGVAL-SS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Philips Respironics
Study Sponsor Philips Respironics
Collaborators Not Provided
Investigators Not Provided
PRS Account Philips Respironics
Verification Date January 2019