Validating Innovative Biosensors for Rett Autonomic Symptom Tracking (VIBRANT)

Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in the use of these devices in clinical trials. VIBRANT will use several FDA-cleared wearable biosensors and a non-wearable device to collect symptom data from patients with Rett syndrome for up to 9 weeks. Symptoms of interest include heart rate, breathing, sleep, blood oxygen levels, and movement. Participants will use the biosensors intermittently at home, document device use and symptom status, and will come to the clinic for 1 overnight sleep study. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.

The study will provide information on the feasibility and ease of use for families at home, biosensor data will be compared to data collected at the same time from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome, and Emerald will be developed to include movement as a measurable symptom.

Study Overview

• Status: Recruiting
• Conditions: Rett Syndrome

Detailed Description

Clinical trials in Rett syndrome typically use subjective assessment scales to assess changes in symptoms. These scales require observer interpretation and can be subject to bias and placebo effect. They are often not fit for purpose, are adapted from other disorders, are not properly validated for use in Rett and therefore are not optimal tools to accurately and reliably assess symptom change.

The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in these devices for use in clinical trials. VIBRANT will use several biosensors to collect symptom data from patients with Rett syndrome over 9 weeks. The devices under study include the FDA-cleared VV330 ECG patch for heart rate, Kids O2 pulse oximeter ring for blood oxygen levels; and the non-wearable device Emerald for sleep, breathing, and movement.

To be eligible, participants will have an MECP2 genetic variant considered causative for the disorder. Participants will come to the clinic for Screening for an eligibility assessment and will learn to use the biosensors. Participants will use the biosensors on an intermittent schedule at home for between approximately 4 to 9 weeks, depending on the device, and will come to the clinic for 1 overnight sleep study during the 9-week observation period. All devices will be used during the overnight sleep study. The data collected by the biosensors will be compared to the data collected from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.

The goals of the study are to demonstrate FDA-cleared devices to assess heart rate, breathing, and oxygen saturation can be reliably used in Rett individuals, both adult and pediatric; determine how accurate and reliable the biosensor results are compared to the overnight sleep study, or to other FDA-cleared devices at home; to and to develop Emerald's ability to assess movement.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Jana von Hehn, PhD; Phone Number: 203-444-1587; Email: jana@rsrt.org
• Study Contact Backup: Name: Jennifer Reynolds; Phone Number: 203-445-0041; Email: jenny@rsrt.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Giulia DiMarco Study Coordinator; Phone Number: 312-942-9841; Email: Giulia_DiMarco@rush.edu
      • Principal Investigator: Pallavi Patwari, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Principal Investigator: David Lieberman, MD, PhD
      • Contact: Shelley Coughlin; Phone Number: 857-218-3842; Email: Michelle.Coughlin@childrens.harvard.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Baylor College of Medicine
      • Contact: study coordinator
      • Principal Investigator: Bernhard Suter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants must have a documented genetic variant in MECP2 considered causative for Rett syndrome, must be generally healthy, able to tolerate device use.

Description

Inclusion Criteria:

• diagnosis of Rett syndrome with a causative MECP2 genetic variant
• Access to WiFi

Exclusion Criteria:

• Inability of participant to sleep alone
• prolonged absence from home
• medication use that may impact heart rate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Main; Participants who are not in a separate interventional treatment trial
Intervention; Participants who are also in a separate interventional treatment trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess heart rate variability with Vivalink VV330 ECG patch	Use FDA-cleared Vivalink VV330 patch to directly and objectively measure heart rate parameters	4 weeks
Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring	Use FDA-cleared Viatom Kids O2 pulse oximeter ring to directly and objectively measure blood oxygen levels	6 weeks
Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG	Comparison of results from ECG patch to PSG ECG results to determine accuracy and reliability	During PSG comparison (1 night)
Validate ECG-derived breathing compared to in-lab PSG	Comparison of results from ECG-derived breathing to PSG breathing results to determine accuracy and reliability	During PSG comparison (1 night)
Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter	Comparison of results from pulse oximeter ring to PSG pulse oximeter results to determine accuracy and reliability	During PSG comparison (1 night)
Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG	Compare Emerald to directly and objectively measure sleep and night time breathing	During PSG comparison (1 night)
Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator	Compare Emerald to FDA-cleared SleepView home sleep test to directly and objectively measure sleep and night time breathing	9 weeks
Develop Emerald ability to measure daytime movement	Compare Emerald signals of movement with video	9 weeks

Collaborators and Investigators

• Sponsor: Rett Syndrome Research Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: biosensor; device; MECP2; RTT; Emerald; sensor; Rett; Vivalink; Kids O2
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Heredodegenerative Disorders, Nervous System; Intellectual Disability; Genetic Diseases, X-Linked; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; X-Linked Intellectual Disability; Rett Syndrome
• Other Study ID Numbers: SENS-102-RSRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No