An EnsoSleep PPG FAQ: What it is, how it works, and why it matters, plus all the answers to common questions
EnsoSleep PPG is an FDA-cleared, AI-powered sleep diagnostic software as a medical device (SaMD). EnsoSleep PPG establishes sleep quality by analyzing, displaying, and summarizing PPG data collected during sleep using compatible FDA-cleared pulse oximetry (pulse ox) devices.
What is a pulse oximeter?
Pulse oximeters (pulse ox) record physiological data related to sleep and breathing, such as a patient’s oxygen saturation levels and heart rate. Pulse ox devices are small, inexpensive, reusable, and widely available, especially compared to earlier generations of sleep diagnostic equipment. They can be as simple to wear as a ring or watch, so patients do not have to struggle with at-home testing set-up. When combined with EnsoSleep PPG, FDA-cleared pulse ox devices can provide a high quality, accessible, and cost-effective approach to diagnosing sleep disorders.
How does EnsoSleep PPG work?
EnsoSleep PPG’s deep learning models analyze data collected by pulse ox devices and automatically detect respiratory events, including sleep disordered breathing events, sleep stages including REM, deep sleep, light sleep, and wake, and other sleep measures. EnsoSleep PPG outputs this analysis which is reviewed and edited by a qualified healthcare professional and then exported into a final sleep report for patient diagnosis and treatment.
How is EnsoSleep PPG designed to be used?
EnsoSleep PPG is designed for use by and on order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults.
What signals are inputs for EnsoSleep PPG?
The minimum input signals that EnsoSleep PPG captures and analyzes to produce outputs include Saturation of Peripheral Oxygen (SpO2), Photoplethysmogram (PPG), and Pulse Rate. Additional inputs may be gathered or presented depending on availability, e.g. actigraphy.
What events does EnsoSleep PPG identify?
EnsoSleep PPG identifies the following:
- Apnea-Hypopnea Index (eAHI)
- Respiratory Events (Apneas or Hypopneas): Obstructive, Central
- Sleep-Wake Events: Wake, Light Sleep, Deep Sleep, REM
- Total Sleep Time (TST) and Total Recording Time (TRT)
- Sleep Efficiency (SE), Sleep Latency (SL)
- Wake After Sleep Onset (WASO)
- Desaturation: Count, Index per Hour
- Heart Rate: Min, Max, Mean, % of Time in Range
- SpO2 / Oxygen Saturation: Min, Max, Mean, % of Time in Range
What does EnsoSleep PPG output for Clinical Review?
EnsoSleep PPG outputs an overall patient sleep analysis which is reviewed and edited by a qualified healthcare professional and exported into a final sleep report for patient diagnosis and treatment.
Which key metrics demonstrate clinical efficacy of EnsoSleep PPG?
While there are many statistically significant values in EnsoSleep PPG, the three that stand out most are the 92% sensitivity for detecting sleep apnea, the 5.5 minute average differential between PSG and EnsoSleep PPG total sleep time, and the 84% overall positive agreement when analyzing REM.
- With a >92% sensitivity for sleep apnea at 3% desaturation, EnsoSleep PPG can correctly identify positive sleep apnea in more than 9 out of 10 patients on a single night of data.
- With an average difference of just 5.5 minutes when comparing EnsoSleep PPG Total Sleep Time to PSG, EnsoSleep PPG provides a more accurate denominator for the AHI than traditional HSATs. Sleep time analysis is one of the functions specifically called out in CPT code 95800, showing that payors also care about reporting total sleep time.
- When a person is experiencing REM sleep, EnsoSleep PPG has a greater than 84% positive agreement, precision on par with human sleep techs scoring a PSG.
What pulse ox devices are compatible with EnsoSleep PPG?
Not all pulse ox devices are compatible with EnsoSleep PPG. To be compatible, pulse oximeters must be FDA-cleared and must meet the EnsoSleep PPG compatibility specifications.. Reach out to the pulse ox manufacturer, or reference the FDA website, www.fda.gov, for more information.
Ultimately, why is EnsoSleep PPG important?
With this new FDA clearance, EnsoSleep PPG will provide more opportunities for clinicians to effectively reach an undiagnosed patient population.
“Expanding EnsoData’s capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep disordered breathing events, including sleep apnea,” said Justin Mortara, President and CEO of EnsoData.
By lowering the barrier for patients to receive an accurate sleep test to more widely available pulse ox devices, clinicians can expedite the diagnostic process and provide patients with answers to their health problems more quickly.
The Future Impact of EnsoSleep PPG is Bright
Expanding EnsoData’s capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep disordered breathing events, including sleep apnea.
Our interoperable AI tools are democratizing the ability to accurately measure sleep and aid in diagnosis of sleep disorders broadly – for the existing category of FDA-cleared pulse oximetry devices and sensors that are already widely deployed, in-use clinically, and growing in their adoption daily.
To learn more about EnsoSleep PPG, head over to that page: www.ensodata.com/ensosleep-ppg/
