VIBRANT Study: Validating Biosensors for Rett Syndrome
The VIBRANT study is looking for people with Rett syndrome to help test wearable devices that measure symptoms like heart rate, breathing, sleep, and blood oxygen levels. Currently, doctors often rely on subjective scales to assess these symptoms, which can be less accurate. This study aims to validate devices like the Vivalink VV330 ECG patch and Viatom Kids O2 pulse oximeter ring to provide more objective and reliable measurements. You can join if you have a confirmed Rett syndrome diagnosis with a specific genetic change (MECP2 variant) and access to WiFi. The goal is to make these devices trustworthy for use in future clinical trials. The study plans to enroll 30 participants.
- Study design
- This is an observational study, meaning no new treatments are being tested. It aims to enroll 30 participants to validate biosensors for up to 9 weeks.
- What's involved
- You will use biosensors intermittently at home for about 4 to 9 weeks, document their use, and attend one overnight sleep study at the clinic.
- Compensation
- Not stated in the trial record.
- Follow-up
- Heart rate variability will be measured at 4 weeks, and blood oxygen levels at 6 weeks. Device validation against in-lab PSG will occur during one overnight comparison.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Validating Innovative Biosensors for Rett Autonomic Symptom Tracking
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Assess heart rate variability with Vivalink VV330 ECG patch4 weeks
Use FDA-cleared Vivalink VV330 patch to directly and objectively measure heart rate parameters
- Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring6 weeks
Use FDA-cleared Viatom Kids O2 pulse oximeter ring to directly and objectively measure blood oxygen levels
- Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSGDuring PSG comparison (1 night)
Comparison of results from ECG patch to PSG ECG results to determine accuracy and reliability
- Validate ECG-derived breathing compared to in-lab PSGDuring PSG comparison (1 night)
Comparison of results from ECG-derived breathing to PSG breathing results to determine accuracy and reliability
- Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeterDuring PSG comparison (1 night)
Comparison of results from pulse oximeter ring to PSG pulse oximeter results to determine accuracy and reliability
- Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSGDuring PSG comparison (1 night)
Compare Emerald to directly and objectively measure sleep and night time breathing
- Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator9 weeks
Compare Emerald to FDA-cleared SleepView home sleep test to directly and objectively measure sleep and night time breathing
- Develop Emerald ability to measure daytime movement9 weeks
Compare Emerald signals of movement with video