WEAR STUDY - Biosensors

We are currently recruiting for a biosensors study taking place at Boston Children’s Hospital to test two biosensors on individuals with Rett syndrome. The purpose of the study is to identify objective measures for symptom improvement in clinical trials. Your participation could help revolutionize how we test the effectiveness of treatments for Rett.

This study involves one in-person visit to the Boston Children’s Rett Clinic followed by four weeks of at-home data collection with a wearable biosensor patch and a freestanding device that is placed in the home. The biosensor patch will be worn two days a week for four weeks. The freestanding device will collect data whenever the individual with Rett is nearby; for this study we are collecting overnight data, so it will be in the child's room. Caregivers will answer questions electronically each day of the four-week period about their child’s sleep, anxiety, and seizures. At the end of the four-week observation period, the biosensors will be mailed back to Boston Children’s Hospital and parents can get a report of their child’s biosensor data.

This study is currently enrolling a small number of participants. To be eligible, you must be able to travel to Boston Children’s Hospital and have a daughter diagnosed with Rett syndrome confirmed by a genetic mutation in the MECP2 gene. Additional requirements apply. To 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 two biosensors being tested in the Boston Children’s biosensors study can directly measure physiological symptoms, such as heart rate, breathing, movement, and sleep.

The wearable biosensor patch, called the MC10 nPoint, is about the size of a large band aid and is worn on the chest. It collects physiologic information about the body, including heartbeat, breathing, position, movement. The patch is easy to use and generates high-quality data. The patch study will collect heartbeat data to develop a way to measure breathing abnormalities in Rett syndrome. Heartbeat and breathing are inextricably connected, so data about a person’s heartbeat will reveal important information about their breathing patterns.

The freestanding device, called the Emerald, is a new kind of invisible biosensor that uses radio waves to collect information without touching the body (therefore it is “invisible” as opposed to “wearable”). Data that the Emerald can collect includes information about breathing, movement, and sleep. This device is being tested for the first time in people with Rett syndrome to see how well it measures Rett symptoms.

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, which are the main assessment tools used in clinical trials today, are not objective because they require parents and clinicians to make subjective interpretations of how the child is doing.

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.

To learn more about the study please visit ClinicalTrials.gov.