Validation of Sleepware G3 Autoscoring Algorithm

January 4, 2019 updated by: Philips Respironics
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any retrospective, de-identified adult polysomnogram collected using American Society of Sleep Medicine (AASM) criteria.

Description

Inclusion Criteria:

  • AASM Compliant PSG studies

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Respironics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Dx-1152-SWGVAL-SS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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