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A New Study

We’re starting our new biosensor study: VIBRANT (Validating Innovative Biosensors in Rett for AutoNomic Symptom Tracking).

The purpose of the study is to test wearable FDA-cleared biosensors and the freestanding Emerald sensor in order to create reliable and precise measurements of Rett syndrome symptoms for clinical trials and healthcare management. These symptoms include: sleep, breathing, heart rate, movement and oxygen saturation, to name a few.

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Your participation could help revolutionize how we test
the effectiveness of treatments for Rett.

The Future is Now

Before genetic medicines for Rett can become a reality for our loved ones, we must prove that the medicines actually work. We know a drug or genetic medicine is working when it meets objective measurements of effectiveness. To date, Rett clinical trials have relied on surveys and questionnaires as the main assessment tools. These tools rely on parents and clinicians interpreting how they think their child and patient is doing and are therefore prone to subjectivity and vulnerability to placebo effect. Observation from parents is important, but it shouldn’t be the sole source of data gathered.

Biosensors measure symptoms directly in the patient with unparalleled precision and consistency leaving little margin for error. Imagine the difference between observing your child’s breathing over several weeks, and then answering questions about that period of time using just your memory, versus using a digital device that collects and analyzes every single breath.

Every biopharmaceutical company we engage with expresses interest in using biosensor data in clinical trials. We believe biosensors are the wave of the future for clinical trials and the future is now.

VIBRANT Study Locations

Boston Children's Hospital
Rush University

So How Does it Work?

The VIBRANT study involves a single in-person visit where your child will wear the biosensors during their overnight stay in the sleep lab, then take the biosensors home to continue to collect data. The sensors will be worn between two to four days a week for four weeks, with this valuable data being fully accessible to parents in order to learn more about their child’s symptoms.

The Emerald device will also collect nightly data on sleep, breathing, as well as movement information for up to nine weeks. Caregivers will be required to answer a few questions electronically each day about their child’s health.

At the end of the nine-week study period, simply mail the equipment back to the participating site where it was issued.

The study is enrolling a small number of participants for the time being with hopes to expand in the future. In order to be eligible, you must be able to travel to the participating site, be at least four years old, and have a confirmed Rett diagnosis with an MECP2 mutation. Some additional requirements apply. To learn more and to be contacted by a research coordinator for the study, sign up below.

Request for Information

The more we know about these sensors, the sooner they can be of use in clinical trials to collect precious data needed much faster, easier, more reliably, and more accurately.

More Details About the Study

All the biosensors, with the exception of Emerald, are FDA-cleared. This means the FDA has reviewed and cleared them as accurate and reliable devices to gather information when patients are away from the clinic. These are incredibly more precise compared to the “gold standard” that would normally occur in a hospital or doctor’s office, making the data gathered incredibly valuable.

The biosensors are all comfortable and will be worn on the chest, abdomen, and/or on a finger. However, the Emerald device doesn’t require wearables at all, it just collects reflections of radio waves as the body moves in the home. Together they collect physiologic information about the body, including heartbeat, breathing, position, movement, sleep, and oxygen saturation. We’re hoping these devices will help the biopharmaceutical companies working towards Rett cures to gauge the following: Can parents easily use them, the quality of the data generated, and whether they’re as effective for Rett patients as they are in other disorders.

We’re hoping to grow the program to include more symptom data with these technologies and continue to expand our understanding of what can be measured reliably from home. These potential studies will focus on symptoms like oxygen saturation, as well as determining whether breathing patches provide more efficient measurements than a breathing belt, and we’ll learn if we can use heart rate to identify breathing patterns or disruptions in breathing.

Emerald will also provide some important information on whether it can replace current techniques with a major advantage being that parents don’t have to do anything to use it after initial setup. It passively collects information via harmless radio waves and doesn’t need to be worn, charged, or have data uploaded manually. We’re excited to expand the use case for Emerald to include movement as well.

Take Action

It’s not a question of “if” we’ll find cures, but “when”. You’re one click away from bringing that day closer.