Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• diagnosis of Rett syndrome with a causative MECP2 genetic variant

• Access to WiFi

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Texas
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Jana von Hehn, PhD
jana@rsrt.org
203-444-1587
Backup
Jennifer Reynolds
jenny@rsrt.org
203-445-0041
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Main
Participants who are not in a separate interventional treatment trial
Intervention
Participants who are also in a separate interventional treatment trial
Related Therapeutic Areas
Sponsors
Leads: Rett Syndrome Research Trust

This content was sourced from clinicaltrials.gov