Clinical trial NCT06338267: Validating Innovative Biosensors for Rett Autonomic Symptom Tracking
Official title: Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rett Syndrome
Keywords: Rett
MECP2
RTT
device
biosensor
Emerald
RespiraSense
Vivalink
Kids O2
sensor
Lead sponsor: Rett Syndrome Research Trust
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must have a documented genetic variant in MECP2 considered causative for Rett syndrome, must be generally healthy, able to tolerate device use.

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.

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 Emerald's ability to assess movement.

Eligibility criteria: 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

Primary outcomes:
measure: Assess breathing rate and apnea (breath holds) with RespiraSense
timeFrame: 6 weeks
measure: Assess heart rate variability with Vivalink VV330 ECG patch
timeFrame: 4 weeks
measure: Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring
timeFrame: 6 weeks
measure: Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG
timeFrame: During PSG comparison (1 night)
measure: Validate ECG-derived breathing compared to in-lab PSG
timeFrame: During PSG comparison (1 night)
measure: Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG
timeFrame: During PSG comparison (1 night)
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
timeFrame: During PSG comparison (1 night)
measure: Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG
timeFrame: During PSG comparison (1 night)
measure: Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator
timeFrame: 9 weeks
measure: Develop Emerald ability to measure daytime movement
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: