Validating Innovative Biosensors for Rett Autonomic Symptom Tracking
ConditionRett Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRett Syndrome Research Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
diagnosis of Rett syndrome with a causative MECP2 genetic variant
Access to WiFi
Disqualifiers
Inability of participant to sleep alone
prolonged absence from home
medication use that may impact heart rate
Trial population
Participants must have a documented genetic variant in MECP2 considered causative for Rett syndrome, must be generally healthy, able to tolerate device use.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Main
Group B: Intervention
Trial outcomes
Primary outcomes
1
Assess heart rate variability with Vivalink VV330 ECG patch
Use FDA-cleared Vivalink VV330 patch to directly and objectively measure heart rate parameters
Time frame
4 weeks2
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
Time frame
6 weeks3
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
Time frame
During PSG comparison (1 night)4
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
Time frame
During PSG comparison (1 night)Sponsors and contacts
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Source ClinicalTrials.gov