Validating biosensors for tracking symptoms in Rett syndrome
Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking
This study is testing if wearable devices can accurately track symptoms in people with Rett syndrome over nine weeks to help doctors understand their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Rett Syndrome Research Trust Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT06338267 on ClinicalTrials.gov |
What this trial studies
The VIBRANT study aims to validate the use of FDA-cleared biosensors to objectively measure symptoms in patients with Rett syndrome over a period of up to 9 weeks. Participants will use various wearable and non-wearable devices to collect data on heart rate, breathing, sleep, blood oxygen levels, and movement, while also documenting their symptom status. The study will compare biosensor data with results from an overnight sleep study to assess the devices' effectiveness. This approach seeks to improve the accuracy of symptom assessment in Rett syndrome, moving away from subjective scales that may introduce bias.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Rett syndrome who have a causative MECP2 genetic variant.
Not a fit: Patients who cannot sleep alone or have medication that affects heart rate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for tracking symptoms in Rett syndrome, leading to better management and treatment options.
How similar studies have performed: While the use of biosensors in clinical settings is gaining traction, this specific approach in Rett syndrome is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 2 other locations
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Jana von Hehn, PhD
- Email: jana@rsrt.org
- Phone: 203-444-1587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.