From the definition of a proof of concept study to the development and testing of the required technical infrastructure Digital therapies are evidence-based therapeutic interventions that use software to prevent, manage, or treat a medical disorder or disease. Not only they require carefully planned clinical studies, but they require also a suitable technical infrastructure not to lose or compromise relevant information. Consequently, careful software testing and monitoring is necessary to ensure that the technical infrastructure is working correctly during the study. In this talk we will describe the entire process used for the analysis of the effectiveness of Nearine, a digital therapy for the management of depressive symptoms based on interoceptive stimulation through vibrations applied on the wrist. We will start with the description of the remote proof of concept study used for the assessment of the effectiveness and potential adverse effects. After that, the technical infrastructure necessary for the study will be outlined. Finally we will show how the usage of CatchSolve for software testing has decreased the risk of potential loss of information during the study. The talk is the result of a joint collaboration between CatchSolve, software testing startup based in NOI Techpark, and Nearine, a new digital health and neurotechnology startup based in Bolzano.

1. Software testing for remote proof
of concept studies of digital therapies

2. Chiara Masci
CEO of Nearine
Nearine
Startup that is developing a
digital therapy for
depressive symptoms and
psychological stress
Davide Montesin
CEO of Catchsolve
What is Catchsolve?
Company focused on
software testing and data
quality solutions for
companies

5. Digital therapies are software programs certified as
medical devices with proven clinical outcomes
to be used as treatments for given conditions

6. Digital therapies are software programs certified as
medical devices with proven clinical outcomes
to be used as treatments for given conditions
Pilot studies and clinical trials are required

7. Quite expensive Highly prone to errors
Pilot studies and clinical trials

8. Bureaucratic
procedures
Failures of the digital
infrastructure
Highly prone to errors
Erroneous
study design

9. Bureaucratic
procedures
Failures of the digital
infrastructure
Highly prone to errors
Erroneous
study design

10. how to use software testing to reduce the risk of failure of
pilot studies and clinical trials of digital therapies

11. Nearine’s digital
therapy
How the study
protocol impacts the
digital infrastructure
Automated software
tests for pilot studies
of digital therapies

12. The digital therapy

13. Digital therapy for improving the
effectiveness of psychotherapeutic
treatments for depression
Nearine decreases up to 50% of the symptoms
in 4 weeks and helps at the identification
of the psycho-social causes that have led to the
development of depression

14. Affective touch acts
as antidepressant
because it stimulates
the insular cortex
Eggart, M., Queri, S., & Müller-Oerlinghausen, B. (2019). Are the antidepressive effects of massage
therapy mediated by restoration of impaired interoceptive functioning? A novel hypothetical
mechanism. Medical Hypotheses, 128, 28-32.
Insular cortex
Thalamus
Spinal cord
Skin sensory input
Caress-like touch

15. The insular cortex is responsible
for self-awareness
and emotional regulation.
It is less active
in depressed people
Casals-Gutierrez, S., & Abbey, H. (2020). Interoception, mindfulness and touch: A meta-review of
functional MRI studies. International Journal of Osteopathic Medicine, 35, 22-33.
Insular cortex

16. Vibration on the wrist
for stimulating antidepressant
effects of affective touch

17. From the study protocol
to the digital infrastructure

18. Goals and
metrics
Study protocol
Study
design
Assessment
methodology

19. Background
information
Goals and metrics
Purpose and
objectives
Endpoints and
outcomes

20. Study
characteristics
Study design
Exclusion and
inclusion of subjects
Treatment
Type of study, number of centers,
enrollment of targets, number of
participants, number of groups and
randomization methods, allocation
& blinding, study duration and
phases

21. Assessment
of safety and
effectiveness
Assessment methodology
Statistics
for endpoints
Data recording

22. Study protocol
Functionalities and connectivity
aspects of the digital infrastructure

23. Assessing technical risks
and designing automated
software tests

24. Software bugs are errors
that produce unintended
or unexpected results

25. The only poison for bugs
is software testing, but it is often
skipped due to repetitiveness
and total focus on development of
features

26. Application testing
Web application that runs
autonomously tests by pretending to
be a user
It collects all the steps that are done by
the fake user and all the errors in a
user-friendly way
Everything without the need to distract
the software developers from their job

27. Data quality testing
Web application that tests the
completeness, validity, accuracy,
timeliness, integrity and consistency of
datasets
The tests can be configured based on
what features of the data quality have
to be tested.
The tests can be scheduled in order to
keep the data quality monitored

28. Which features of
a digital therapy
should be tested?

29. Severity
likelihood
Decide what to test
based on the likelihood
of the issues and the
severity of their
consequences

30. Two are the biggest
issues during a pilot
study: losing data or
having wrong data

31. Data loss can be caused
by issues related to the
communication between
the device and the server
without a proper backup
system

32. While inaccurate data
could be caused by
issues related to the
sensors and/or to the
usage of the system by
the patient

33. Using data quality testing
we can anticipate the
issues and fix them before
the end of the study by
analyzing the incoming data

34. In conclusion…

35. Chiara Masci
CEO of Nearine
LinkedIn
Nearine
Website
nearine.com (desktop)
m.nearine.com (mobile)
Davide Montesin
CEO of Catchsolve
LinkedIn
CatchSolve
Website
catch-solve.tech