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WEAR STUDY - Biosensors

Get ready! We’re about to start our new VIBRANT biosensor study (Validating Innovative Biosensors in Rett for AutoNomic Symptom Tracking)! The VIBRANT study will take place at Boston Children’s Hospital, Rush University, and Baylor College of Medicine/Texas Children’s Hospital to test several wearable FDA-cleared biosensors and the freestanding invisible Emerald sensor. The purpose of the study is to create reliable objective measurements of Rett syndrome symptoms for clinical trials, including sleep, breathing, heart rate, and oxygen saturation. Emerald will also be used to develop the ability to measure movement in Rett. Your participation could help revolutionize how we test the effectiveness of treatments for Rett.

This study is for individuals who need an overnight sleep study in a sleep lab. The VIBRANT study involves one in-person visit to get the biosensors, wearing the biosensors during their overnight stay in the sleep lab, and up to 9 weeks of at-home data collection. The wearable sensors will be worn between 2 and 4 days a week for 4 weeks with data available for parents to learn more about their child’s symptoms. The Emerald will collect data on sleep and breathing every night, and will collect movement information a few times a week for up to 9 weeks. Caregivers will answer questions electronically each day about their child’s health. At the end of the 9-week study period, the biosensors will be mailed back to the site and parents can get a report of their child’s Emerald data.

This study is currently enrolling a small number of participants. To be eligible, you must be able to travel to the participating site and have a child at least 4 years old diagnosed with Rett syndrome confirmed by a genetic mutation in the MECP2 gene. Additional requirements apply. To learn more or be contacted by a research coordinator for the study to determine your eligibility, sign up below.

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More about the study

The biosensors being tested can directly measure physiological symptoms, such as heart rate, breathing, movement, and sleep, and all except Emerald are FDA-cleared. That means FDA has reviewed the sensors and cleared them as accurate and reliable compared to the “gold standard” that would normally occur in a hospital or doctor’s office, making the sensors an easier way to get the same accurate and reliable information when patients are away from the clinic.

The wearable sensors being studied in VIBRANT are worn on the chest and abdomen, or on a finger. The Emerald doesn’t touch the body at all, and just collects reflections of radio waves as the body moves in space (imagine ripples on the surface of a pool bouncing back when they hit the edge). Together they collect physiologic information about the body, including heartbeat, breathing, position, movement, sleep, and oxygen saturation. We are hoping to learn how well these sensors measure individuals with Rett syndrome compared to the gold standard devices. These comparisons will help companies working to cure Rett understand if parents can easily use them, if they generate high quality data, and if they are as accurate in individuals with Rett syndrome as they are in other groups of individuals. The more we know about these sensors in individuals with Rett, the easier it is to include them in clinical trials, making data collection faster, easier, more reliable, and more accurate.

We’re hoping to expand what symptoms we can measure for Rett, including those that can’t be observed by someone else, like oxygen saturation and heart rate, and learn what can we measure reliably from home with these technologies. We will learn if oxygen saturation is a good symptom to measure at home. We will learn if a breathing patch is better at measuring breathing than a breathing belt, and we’ll learn if we can use heart rate to see the breathing pattern or disruptions in breathing.

Emerald, the invisible biosensor that uses radio wave reflections to collect information without touching the body (therefore it is “invisible” as opposed to “wearable”) will also be compared to gold standards to show how reliably it can be used in Rett. The advantage of Emerald is that parents don’t have to do anything to use it. It passively collects information, doesn’t need to be worn or removed, charged, or uploaded. We’re excited to expand the use case for Emerald from breathing and sleep to include movement as well.

How the study will move the needle for a cure

Before a treatment for Rett can become available for our loved ones, we must prove that the treatment works – and we know a drug definitively works when it meets objective measurements of efficacy. Symptom assessment surveys, or questionnaires, are the main assessment tools used in clinical trials today, and are not objective because they require parents and clinicians to observe and then judge and interpret how the participant is doing. There can be so much noise with these measurements that one clinician and one parent typically completes the survey during the course of a trial, because even parents of the same individual don’t rate that individual the same!

Because digital tools measure symptoms in the patient directly and exactly the same way every time, these objective measurement tools help us better assess the effects of a drug on the patient and help us see more clearly whether or not a drug is effective. Imagine the difference between thinking about your child’s breathing over the past 2 or 4 weeks, and then answering questions about what you remember or think you saw during that time, and using a digital tool that was monitoring your child’s breathing every day, capturing each breathing event and how long it lasted, and then providing metrics that quantify those events by count per hour and how long each one lasted. Which approach do you think would be a better way to see if a drug was improving breathing symptoms?

Every biopharmaceutical company RSRT engages with expresses interest in using biosensor data in clinical trials, and these measurements are without a doubt the future of trial data collection.