NCT06338267 Validating Innovative Biosensors for Rett Autonomic Symptom Tracking
| NCT ID | NCT06338267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rett Syndrome Research Trust |
| Condition | Rett Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-03-03 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06338267 clinical trial?
This trial is open to participants of all sexes, studying Rett Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06338267 currently recruiting?
Yes, NCT06338267 is actively recruiting participants. Contact the research team at jana@rsrt.org for enrollment information.
Where is the NCT06338267 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Houston, United States.
Who is sponsoring the NCT06338267 clinical trial?
NCT06338267 is sponsored by Rett Syndrome Research Trust. The trial plans to enroll 30 participants.