Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking
Sponsor:
Rett Syndrome Research Trust
Organization:
Rett Syndrome Research Trust
Study Overview
Official Title:
Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIBRANT
Brief Summary:
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
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
Detailed Description:
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 devices of RespiraSense for breathing 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 Emeralds ability to assess movement
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 devices of RespiraSense for breathing 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 Emeralds ability to assess movement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None