Rett Syndrome Clinical Trial
— VIBRANTOfficial title:
Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking
NCT number | NCT06338267 |
Other study ID # | SENS-102-RSRT |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | May 2025 |
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Rush University | Chicago | Illinois |
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Rett Syndrome Research Trust |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess breathing rate and apnea (breath holds) with RespiraSense | Use FDA-cleared RespiraSense to directly and objectively measure breathing | 6 weeks | |
Primary | Assess heart rate variability with Vivalink VV330 ECG patch | Use FDA-cleared Vivalink VV330 patch to directly and objectively measure heart rate parameters | 4 weeks | |
Primary | Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring | Use FDA-cleared Viatom Kids O2 pulse oximeter ring to directly and objectively measure blood oxygen levels | 6 weeks | |
Primary | Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG | Comparison of results from ECG patch to PSG ECG results to determine accuracy and reliability | During PSG comparison (1 night) | |
Primary | Validate ECG-derived breathing compared to in-lab PSG | Comparison of results from ECG-derived breathing to PSG breathing results to determine accuracy and reliability | During PSG comparison (1 night) | |
Primary | Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG | Comparison of results from RespiraSense to PSG breathing results to determine accuracy and reliability | During PSG comparison (1 night) | |
Primary | Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter | Comparison of results from pulse oximeter ring to PSG pulse oximeter results to determine accuracy and reliability | During PSG comparison (1 night) | |
Primary | Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG | Compare Emerald to directly and objectively measure sleep and night time breathing | During PSG comparison (1 night) | |
Primary | Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator | Compare Emerald to FDA-cleared SleepView home sleep test to directly and objectively measure sleep and night time breathing | 9 weeks | |
Primary | Develop Emerald ability to measure daytime movement | Compare Emerald signals of movement with video | 9 weeks |
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