Cardiac patch joins monitoring devices of VIBRANT study

Trial aims to validate digital sensors of Rett symptoms to speed therapy work

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by Steve Bryson, PhD |

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The Rett Syndrome Research Trust (RSRT) has partnered with Vivalink to use its Multi-Vital ECG wearable patch to monitor heart rate in people with Rett syndrome participating in the observational VIBRANT study.

VIBRANT (NCT06338267) is set to enroll about 30 Rett patients at sites in Illinois, Massachusetts, and Texas. As an observational study, rather than a trial of potential treatments, its goal is to validate digital devices that “objectively and directly” monitor vital parameters associated with the autonomic nervous system, which controls unconscious bodily processes like breathing, heart rate, and digestion.

Autonomic dysfunction in Rett syndrome has been linked to many disease symptoms, such as irregular heartbeats, breathing problems, and sleep disturbances.

In validating a mix of wearable and nonwearable biosensors, the RSRT aims to “create confidence in the use of these devices in clinical trials” of potential therapies, the group states in an overview description of the VIBRANT trial, which RSRT is sponsoring.

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Vivalink’s wearable Multi-Vital ECG monitors heart and breathing rate

Vivalink’s medical-grade, lightweight, and reusable Multi-Vital ECG patch is a wearable heart monitor. On a single charge, it can provide up to 14 days of continuous real-time monitoring of measures that include a patient’s heart rate and its variability, breathing rate, skin temperature, posture, and step count, the company reports.

Rett syndrome mainly is caused by mutations in the MECP2 gene, and symptoms typically emerge in children between 6 and 18 months of age. Normal development begins to slow or regress, and patients experience severe difficulties in movement, breathing, speech, learning, and mood, as well as in the heart and digestive systems.

“Partnering with Vivalink to measure symptoms digitally offers a number of advantages to us and the participants,” Jana von Hehn, PhD, chief scientific officer at RSRT, said in a Vivalink press release. “For example, the interface of the wearable devices allows families to access real-time data, providing them with valuable insights into their loved one’s health.”

These technologies also help to “alleviate the burden on caregivers by automating the process of data collection, reducing the need to manually record and recall information,” von Hehn added.

Other devices being tested in the VIBRANT study, announced in April, include PMD Solutions’ wearable RespiraSense, which tracks breathing patterns, and Kids O2 pulse oximeter ring for blood oxygen levels. All included biosensors have been cleared for use by the U.S. Food and Drug Administration, and will be used in the study to collect symptom data from Rett patients its over nine weeks.

Goal is to validate devices that help in ‘understanding and treating Rett’

Devices that can monitor symptoms not easily observed or measured may be used to develop biomarkers to assess the impact of disease-modifying therapeutics in future clinical trials.

“We are excited to partner with the Rett Syndrome Research Trust in their pioneering study,” said Aaron Timm, chief commercial officer at Vivalink. “We hope to empower researchers with the tools they need to make meaningful advancements in understanding and treating Rett syndrome.”

Eligible VIBRANT patients are those with a disease-causing MECP2 genetic variant who can sleep alone, be away from home, and are not taking medications that affect heart rate.

Enrollment also is open to 10 patients receiving an experimental treatment in a separate clinical trial, who will receive a custom device schedule for up to a year.

Participants will use the biosensors intermittently at home, document their use and Rett symptoms, and attend a single overnight sleep study at a clinic. All devices will be used during the sleep study, and biosensor data will be compared to laboratory data to assess how well they work in Rett patients.

Emerald Innovations will provide nonwearable devices to monitor sleep, breathing, and movement patterns.

Academic researchers at Emory University and the Georgia Institute of Technology, both in Atlanta, are assisting RSRT, a patient advocacy organization that funds disease research worldwide, in the study.