Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment

Summary

Chronic rhinosinusitis (CRS) is a multifactorial disease characterized by persistent symptomatic inflammation of the mucosa of the nose and paranasal sinuses, with (CRSwNP) or without (CRSsNP) the presence of nasal polyps. It affects 5 to 12% of the general population. CRS is often associated with asthma, which has a prevalence of 4% in the general population, reaching 30%-70% among patients with CRS. The current standard clinical evaluation of patients for both diseases has two main components: a subjective one (self-assessment provided by the patient), based mainly on the PROMs (Patient-Reported Outcome Measures) questionnaire, and an objective one (formulated by the clinician). Questionnaires present accuracy and response rate problems that have been investigated in the literature, finding that short questionnaires, incentives, personalization of questionnaires as well as repeat sending strategies or telephone reminders have a beneficial impact on the quantity and quality of responses. Today there are many new channels provided by technology. Among them, AI chatbots have been used in a variety of healthcare domains such as medical consultations, disease diagnosis, mental health support and, more recently, risk communications for the COVID-19 pandemic, and can offer a better way to collect questionnaires. At the same time, the recent technical solution of new non-invasive techniques for RFID radio frequency identification devices allows subjective reports to be accompanied with objective reports.

The PRECISION project aims to evaluate systems for home monitoring of chronic rhinosinusitis (CRS) and asthma, two highly prevalent chronic diseases. The frequent association between the two pathological conditions is a further argument in support of the rationality of a common approach.

As regards the collection of PROMs, three acquisition channels will be compared: i) AI Chatbots; ii) PhoneBot; iii) Mobile application. Data will be analyzed in relation to patient profiles to define the quality and quality of response.

Regarding objective evaluation, the project will investigate the efficiency of objective remote airflow measurements for both upper (CRS) and lower (asthma) airways using dedicated non-invasive systems based on RFID technology.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps
• Asthma

Interventions

DEVICE

Radio Frequency IDentification (RFID) device

RFID devices monitor breathing patterns by means of temperature measurements of the respiratory airflow. The temperature gradient of the air flow in and out of the airways can be correlated to the flow-based respiratory patterns. Accordingly, a temperature-based breath monitoring can be achieved by means of on-skin RFID sensors attached below the nose. Finally, a bilateral measurement of nostrils respiratory flow can provide more information since nasal cavities do not behave in the same way during a respiratory cycle. In this project we will evaluate the possibility to perform domestic breath flow analysis by exploiting thin, lightweight and battery-less sensing plasters directly attached under the nose. The system includes a proper external reader interrogating the face sensors that is capable to directly communicate with smartphone/pc/tablet/cloud environment.

Sponsors & Collaborators

• University of Rome Tor Vergata

  collaborator OTHER

• Azienda Ospedaliero Universitaria di Sassari

  lead OTHER

Principal Investigators

• Francesco Bussu, MD · Azienda Ospedaliero Universitaria di Sassari

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-29

Primary Completion

2025-12-31

Completion

2026-06-30