FDA Cleared Total Sleep Time (TST) for Home Sleep Apnea Testing (HSAT) Devices

EnsoSleep Artificial Intelligence (AI) scoring technology streamlines the delivery and improves the reliability of HSAT results by providing TST via EnsoTST. 

EnsoTST enables the measurement of TST through commonly available data found in HSATs and helps clinicians accurately identify AHI severity levels.

EnsoSleep Total Sleep Time (EnsoTST)

Have Confidence in HSAT Results

EnsoTST uses PPG and respiratory channels to calculate the TST in home tests and helps improve confidence in home sleep testing results and diagnosis for clinicians and patients. TST demonstrated 90% overall agreement compared to ⅔ majority manually scored EEG-based staging and total sleep time.

Navigate the Changing Reimbursement Landscape

Adding EnsoTST to home testing devices that don’t natively track sleep time provides a pathway to increased reimbursement for HSATs, (using CPT code 95800 vs. 95806). For more information regarding billing and coding for HSATs, reference EnsoData’s HSAT and Total Sleep Time Billing and Coding Guide or check with your payer.

  • Increase Confidence in HSAT testing and diagnosis

  • Accurate calculation of AHI severity levels

  • Improve reliability of HSATs

  • Improve quality of care for the HSAT environment

Improve Quality of Patient Care in the HSAT Environment

We’re excited to provide revolutionary AI capability for reliable HSAT and sleep measurement at home.

Simply fill out our form and a team member will reach out to schedule an online demo at your convenience. During the meeting, we’ll discuss the unique needs of your clinic and demonstrate how EnsoSleep with EnsoTST fits into your current workflow.

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EnsoSleep Resources

Discover how EnsoSleep with EnsoTST provides clinicians with more opportunities to focus on patients, and improve the overall quality of care, diagnosis, and treatment for the HSAT environment.

Read our EnsoSleep Performance Reference Document, which includes the results of our clinical validation studies.

EnsoSleep Receives Expanded FDA Clearance for Pediatrics, EnsoViewer, Total Sleep Time (EnsoTST)

In July 2021, the FDA issued a 510(k) clearance for the artificial intelligence software platform EnsoSleep, expanding the AI’s reach to pediatric populations ages 13 and above, and for two additional products to support sleep centers in achieving their goal of providing excellent patient care, EnsoViewer and Total Sleep Time.

EnsoSleep is an FDA cleared AI-assisted sleep scoring and analysis solution that automates the scoring of studies, and reduces the time RPSGTs spend scoring. Consistent, reliable results provide clinicians with more time to expand patient care, improve outcomes and treat more patients.

EnsoViewer is a sleep study reviewing, editing, and reporting tool cleared by the FDA in 2021. Sleep professionals can use EnsoViewer to access all their studies for all their devices, across all locations, in one easy-to-use, interoperable, cloud-based platform.