Validating Innovative Biosensors for Rett Autonomic Symptom Tracking

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rett Syndrome Research Trust
Study ID
NCT06338267
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Main
    Participants who are not in a separate interventional treatment trial
  • Arm: Intervention
    Participants who are also in a separate interventional treatment trial

Primary Outcome Measure

Assess heart rate variability with Vivalink VV330 ECG patch [ Time Frame: 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Giulia DiMarco Study Coordinator
[email protected]
312-942-9841
Pallavi Patwari, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Shelley Coughlin
[email protected]
857-218-3842
David Lieberman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Study Coordinator
Bernhard Suter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILBoston Children's Hospital· Boston, MABaylor College of Medicine· Houston, TX

Related Studies