Sleep Study Scoring and Physician Interpretation
The CISRE’s Data Management Core provides investigators and sponsors with immediate access to sleep recordings and prompt sleep study reports. Its versatile IT backbone combines fixed in-lab and mobile domiciliary testing suites to record, score, analyze and archive raw and summary data. Customized software offers robust, secure mechanisms for transmission of sleep recordings and summary data to and from the Scoring Hub from on-site study beds and remote locations across the globe.
3.1 Scoring Type
Investigators can request a variety of different types of scoring for their protocol’s PSGs. These include:
Sleep Architecture (Limited Scoring)
Standard PSG (Sleep Architecture, Respiratory, Spontaneous Arousals, and PLM)
Specialized Automated Periodic Leg Movement (PLM)
TcCO2 / End-tidal interpretation
Breath-by-breath flow analysis
Breath-by-breath snoring analysis
3.2 Sleep Study Report
A standard sleep study report consists of four pages. 1. Study information, sleep architecture, and PLM. 2. Respiratory breakdown positional analysis. 3. Physician interpretation. 4. Summary chart.
An additional CO2 report may follow the sleep study report upon request. The summary statistics include the average, high, and low TcCO2/SpO2 values for wake, NREM, and REM. The SpO2 variables are categories be level of saturation (mean %, <90%,<85%, <80%). Moreover, summary statistics are available prior to lights off and following lights on.
3.3 Databasing Report Variables
As noted above, report variables are initially provided in PDF format. Investigators within the institute have the benefit of receiving the variables in an Excel spreadsheet array ready for databasing. As additional subjects within any given protocol are added, the CISRE updates the relevant Excel spreadsheet. In addition to standard variables that are included in the PDF and Excel spreadsheets, the CISRE database contains additional variables that are not typically included in standard sleep reports. Should you be interested in learning more about other potential variables, contact the CISRE IT Manager.
3.4 Database queries
Upon request, SQL queries are available to investigators. For example, the CISRE IT team can provide breath-by-breath analysis by stage, position, or demographic. Circulation time and/or event by event associations can also be provided.