NCT07828964Not yet recruiting
The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study
The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Pilot Feasibility Study: Wearable Monitors for Autistic Children With Behavioural Challenges in Emergency Care
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
This is a randomized, unblinded, single-centre, pilot feasibility study. A total of 100 patients will be enrolled and randomized to have their vital signs collected using either the Masimo Radius PPG and Radius T in combination with standard equipment, or only the standard equipment. Within the experimental group, Children will have their HR, RR, SpO2, and T measured using the wearable monitors, specifically the Masimo Radius PPG and Radius T devices that are attached to them wirelessly. Blood pressure (BP) will then be measured using standard equipment in the ED, after obtaining wireless vital signs. For the control group, Children will have their vital signs measured using standard hospital vital sign monitoring equipment. The project will be deemed successful if all primary feasibility thresholds are met and preliminary data show a trend toward reduced time-to-vitals and distress without safety concerns. Additional indicators include clear identification of logistical/training needs, dissemination of findings (peer-reviewed publication, PERC/TREKK networks), and a refined protocol for a definitive trial. Achieving these will demonstrate both proof-of-concept and readiness for multi-centre implementation.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Autism
- NCT number
- NCT07828964
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Sept 2026 to the primary completion date, Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior enrollment in the study
Other illness
- Skin conditions or isolation precautions preventing device placement
- Known allergy or hypersensitivity to foam rubber, adhesive tape, or device adhesive components.
Other
- CTAS 1
- Implanted or adjacent devices that could interfere with sensors
Who the study is looking for
- Age 2 to 17 years
- Suspected or confirmed ASD diagnosis by chart or caregiver
- Presenting to ED visit and requiring vital signs
- Anatomically suitable sites for device placement
- Participant with capacity (including a mature minor) or caregiver/substitute decision-maker able to complete the informed consent process in English. Certified interpreters will not be used to translate the research consent process in this pilot because validated translated consent documents are unavailable.
- Ability to observe the child for at least 30 minutes to measure time-to-vitals and r-FLACC and CFS scores
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.