protocolSection identificationModule nctId: NCT06338267, orgStudyIdInfo id: SENS-102-RSRT, briefTitle: Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking, acronym: VIBRANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Rett Syndrome Research Trust, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Rett Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assess breathing rate and apnea (breath holds) with RespiraSense, primaryOutcomes measure: Assess heart rate variability with Vivalink VV330 ECG patch, primaryOutcomes measure: Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring, primaryOutcomes measure: Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG, primaryOutcomes measure: Validate ECG-derived breathing compared to in-lab PSG, primaryOutcomes measure: Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG, primaryOutcomes measure: Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter, primaryOutcomes measure: Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG, primaryOutcomes measure: Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator, primaryOutcomes measure: Develop Emerald ability to measure daytime movement, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: Pallavi Patawi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: David Lieberman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Baylor College of Medicine, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Study Coordinator, role: CONTACT, contacts name: Bernhard Suter, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False