Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

Rett Syndrome Clinical Trial

— VIBRANT  

Official title:

Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338267
• Other study ID #: SENS-102-RSRT
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Rett Syndrome Research Trust
• Contact: Jana von Hehn, PhD
• Phone: 203-444-1587
• Email: jana[@]rsrt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 Emerald's ability to assess movement.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Rett Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rett Syndrome Research Trust

Country where clinical trial is conducted

United States, 

Outcome

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