Technical Performance Verification Study
Sleep disturbance is common in individuals with post-traumatic stress disorder (PTSD). The gold standard assessment for sleep:wake disturbances is the overnight polysomnogram (PSG), but in-lab PSGs are cumbersome, resource intensive, and not always an accurate reflection of a night of sleep in someone’s home environment. However, there is growing availability of wearable and home sensor devices that can assess sleep:wake patterns in a more efficient, cost-effective way in the home environment.
- To compare biosensors to PSG to assess their accuracy in a population of people with PTSD and insomnia.
- To ensure the devices can detect differences in sleep patterns (including movement of limbs) and determine when these movements are during sleep versus when the individual is awake and moving.
Validation of one or more of these devices is important so they can be a part of other sleep improvement solutions, such as our Sleepwell Platform. To this end, a key first step is to validate that these devices are accurate as compared to the “gold standard” (PSG). There are many devices that claim to measure sleep and other activities, which are entering the market daily. In our EarlySignal device lab, we test these devices – both research grade and consumer grade – to evaluate whether they measure what they are intended to measure e.g., an accurate step count or whether they provide the information needed to calculate someone’s sleep pattern. Based on the device lab results, we selected the most promising six devices and launched a Technical Performance Verification study with our partners, a leading sleep research team at the University of Pennsylvania. Participants in the study, those with both insomnia and PTSD, will help us learn which of these potential sleep assessments is the most accurate against the gold standard.
Study results will be instrumental for the next steps in developing an improved sleep solution for this population, which is to integrate the most accurate device or device combination with other typical sleep information such as sleep diaries found on a treating Clinician’s Dashboard. This combination of objective sleep data from the devices and subjective data from the patient enable best practices for personalizing and effectively restoring sleep and function.
- Technical Performance Verification (TPV) of wearable and home sensor devices for monitoring of sleep in subjects with Post Traumatic Stress Disorder (PTSD)