Validating Innovative Biosensors for Rett Autonomic Symptom Tracking

Официальное название

Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

Обзор

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.

Подробное описание

Clinical trials in Rett syndrome typically use subjective assessment scales to assess changes in symptoms. These scales require observer interpretation and can be subject to bias and placebo effect. They are often not fit for purpose, are adapted from other disorders, are not properly validated for use in Rett and therefore are not optimal tools to accurately and reliably assess symptom change.

The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in these devices for use in clinical trials. VIBRANT will use several biosensors to collect symptom data from patients with Rett syndrome over 9 weeks. The devices under study include the FDA-cleared VV330 ECG patch for heart rate, Kids O2 pulse oximeter ring for blood oxygen levels; and the non-wearable device Emerald for sleep, breathing, and movement.

To be eligible, participants will have an MECP2 genetic variant considered causative for the disorder. Participants will come to the clinic for Screening for an eligibility assessment and will learn to use the biosensors. Participants will use the biosensors on an intermittent schedule at home for between approximately 4 to 9 weeks, depending on the device, and will come to the clinic for 1 overnight sleep study during the 9-week observation period. All devices will be used during the overnight sleep study. The data collected by the biosensors will be compared to the data collected from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome. 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 goals of the study are to demonstrate FDA-cleared devices to assess heart rate, breathing, and oxygen saturation can be reliably used in Rett individuals, both adult and pediatric; determine how accurate and reliable the biosensor results are compared to the overnight sleep study, or to other FDA-cleared devices at home; to and to develop Emerald's ability to assess movement.

Первичные конечные точки

• Assess heart rate variability with Vivalink VV330 ECG patch [Срок оценки: 4 weeks]
• Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring [Срок оценки: 6 weeks]
• Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG [Срок оценки: During PSG comparison (1 night)]
• Validate ECG-derived breathing compared to in-lab PSG [Срок оценки: During PSG comparison (1 night)]
• Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter [Срок оценки: During PSG comparison (1 night)]
• Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG [Срок оценки: During PSG comparison (1 night)]
• Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator [Срок оценки: 9 weeks]
• Develop Emerald ability to measure daytime movement [Срок оценки: 9 weeks]

Критерии участия

Критерии включения

• diagnosis of Rett syndrome with a causative MECP2 genetic variant
• Access to WiFi

Критерии исключения

• Inability of participant to sleep alone
• prolonged absence from home
• medication use that may impact heart rate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• Rush University Medical Center — Chicago
• Boston Children's Hospital — Boston
• Baylor College of Medicine — Houston

Идентификаторы

NCT: NCT06338267 · SENS-102-RSRT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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