Validating Innovative Biosensors for Rett Autonomic Symptom Tracking

NCT06338267 | Recruiting

• 1 other identifier: SENS-102-RSRT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rett Syndrome

Keywords

Rett; MECP2; RTT; device; biosensor; Emerald; Vivalink; Kids O2; sensor

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Main

Participants who are not in a separate interventional treatment trial

Intervention

Participants who are also in a separate interventional treatment trial

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rett Syndrome Research Trust: lead

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Central Study Contacts

Jana von Hehn, PhD

CONTACT

203-444-1587; jana@rsrt.org

Jennifer Reynolds

CONTACT

203-445-0041; jenny@rsrt.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)