RECRUITING

Validating Innovative Biosensors for Rett Autonomic Symptom Tracking

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking

Quick Facts

Study Start:2025-03-03
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06338267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of Rett syndrome with a causative MECP2 genetic variant
  2. * Access to WiFi
  1. * Inability of participant to sleep alone
  2. * prolonged absence from home
  3. * medication use that may impact heart rate

Contacts and Locations

Study Contact

Jana von Hehn, PhD
CONTACT
203-444-1587
jana@rsrt.org
Jennifer Reynolds
CONTACT
203-445-0041
jenny@rsrt.org

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Rett Syndrome Research Trust

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Rett
  • MECP2
  • RTT
  • device
  • biosensor
  • Emerald
  • RespiraSense
  • Vivalink
  • Kids O2
  • sensor

Additional Relevant MeSH Terms

  • Rett Syndrome