Validating Innovative Biosensors for Rett Autonomic Symptom Tracking
NCT ID: NCT06338267
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2025-03-03
2026-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Main
Participants who are not in a separate interventional treatment trial
No interventions assigned to this group
Intervention
Participants who are also in a separate interventional treatment trial
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Access to WiFi
Exclusion Criteria
* prolonged absence from home
* medication use that may impact heart rate
ALL
No
Sponsors
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Rett Syndrome Research Trust
OTHER
Responsible Party
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Locations
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Rush University Medical Center
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Giulia DiMarco Study Coordinator
Role: primary
Shelley Coughlin
Role: primary
Study Coordinator
Role: primary
Other Identifiers
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SENS-102-RSRT
Identifier Type: -
Identifier Source: org_study_id