NCT05340608

Development and Validation of a System for the Anticipation of Challenging Behaviors

Completed Last updated 30 December 2022

What this trial tests

trial testing Smart, non-invasive shirt - Physiological parameters in Autism Spectrum Disorder in 51 participants. Completed in 30 September 2022.

Timeline

1 June 2022

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Ariel University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	51
Start date	1 June 2022
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	1 location across Israel

Drugs / interventions tested

• Smart, non-invasive shirt - Physiological parameters
• Smart, non-invasive shirt - Relation with challenging behaviors
• Smart, non-invasive shirt - Proof of Concept

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Ariel University

Who can join

Adults 20 to 40, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Most people with autism spectrum disorder (ASD) present at least one form of challenging behavior (CB). Self-injurious, aggressive, and disruptive CBs linked with social interaction, community-based service exclusion, and a life quality reduction for people with ASD, their caregivers, and health professionals. The current study has three objectives: 1) to assess the differences in the physiological reaction of high-functioning adults with ASD and typically developed peers, using bio-signal measurements such as heart rate derived from wearable Smart Shirt (SS), 2) to learn which physiological parameters can best predict the imminent onset of a CB, and 3) to develop a system able to predict the incoming occurrence of a CB in real-time and inform the caregiver through an alert notification sent on a smartphone application.

Methods and analysis: comparison between physiological parameters will carry out with two groups of 20 participants with and without ASD. Each participant will be asked to watch two five-minute videos while wearing the SS: one showing relaxing images and the other impressive human body deformities. To identify the matching between the physiological parameters variation collected by the SS and the CBs, ten participants with ASD and aggressive or disruptive CBs will be recruited. Each of these participants will wear the SS for seven consecutive days during waking hours, performing their usual daily activities. During the same seven days, the caregivers who care for the participant will fill a behavioral diary with the participant's status, reporting the times of the day in which he is quiet, agitated and the occurrence of CBs. A learning algorithm capable of predicting immediate CBs occurrence based on physiological parameter variations will be developed together with an ad hoc smartphone application. If the algorithm detects the possibility of an incoming CB, a notification will be sent to the caregiver's smartphone to inform of the possible advent of a CB, therefore enabling the implementation of the selected intervention strategy. After developing the algorithm and related smartphone application, a system efficiency proof of concept (POC) will be carried out with one participant with ASD and CB for seven days in a special school setting with healthcare professionals and teachers. A focus group including health professionals will be conducted after the POC to identify the strengths and weaknesses of the developed system.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and validation of a system for the prediction of challenging behaviors of people with autism spectrum disorder based on a smart wearable shirt: A mixed-methods design.
   Zwilling M, Romano A, Hoffman H, Lotan M, et al · · 2022 · cited 4× · PMID 36523754 · DOI 10.3389/fnbeh.2022.948184