Title: Tutti Toot Trumpet
Funder: Department of Health and Social Care

Abstract: Globally, 70k-100k people have Cystic Fibrosis (CF), 251 million have Chronic Obstructive Pulmonary Disease (COPD) and 339 million (including 6.2 million children) have Asthma. Tutti Toot Trumpet (TTT) is a novel digital medical and musical device for Cystic Fibrosis, Chronic Obstructive Pulmonary Disease and Asthma patients, providing a unique alternative method to clear mucus, exercise the lungs, whilst measuring real time positive expiratory lung pressures, peak flow and performance. Our TTT prototype measures expiratory air pressure, controlling musical therapy games and records analytic data to a dedicated app, which can be viewed by patients and shared with parents and clinicians. The platform enables patients to take ownership, evidence responsibility of their daily therapy and readings. Building the bridge between home and hospital care could impact upon compliance with peer reviews (page 18 https://www.nice.org.uk/guidance/qs168/documents/briefing-paper.) We hope that the collection and viewing of lung pressure/peak flow data will be an indicator of stable, deteriorated, or improved lung health. It could act as a warning indicator to seek clinical advice earlier than routine review appointments or when symptoms have increased. We aim to address the noncompliance and fatigue using current ACT/ peak flow devices by 'gamifying' the TTT (similar to Guitar Hero ), using digital platforms for different age groups of patients, respiratory diseases with differing severity of symptoms and an online community for the competitive or inquisitive. The TTT collects lung pressure/air flow data in an analytic app accessible to patients, parents and clinicians and could be deployed directly to patients with an online training facility. The contact parts of the TTT are designed to be fully sterilised after each use. One way air valves and easy-clean waterproof pressure sensors address typical infection control issues of current ACT devices. CF and COPD patients are extremely susceptible to lung infection. Proof of device infection control will be central for adoption by patients and clinicians. Confirmed PPI activities with the Cystic Fibrosis Trust, Asthma UK and Royal Brompton Hospital COPD team will be key to provide valuable lived experience and feedback, steering the creative and design teams to hone the TTT to be effective. The TTT will have reached TRL3 and we will file a PCT patent application by December 2020. Tutti Toot Ltd will own all new intellectual property arising during the project. The TTT is likely to be a medical device Class IIa, requiring conformity assessment and CE marking. A project with Great Ormond Street Hospital (May 2019) found that expiratory pressures generated while playing wind and brass musical instruments were similar to, or higher than, those targeted by people with Cystic Fibrosis when using Airway Clearance Treatment devices , providing proof of concept for the development of the TTT.

Lay abstract: Globally, 70k-100k people have Cystic Fibrosis (CF), 251 million have Chronic Obstructive Pulmonary Disease (COPD) and 339 million (including 6.2 million children) have Asthma. Tutti Toot Trumpet (TTT) is a novel digital medical and musical device for Cystic Fibrosis, Chronic Obstructive Pulmonary Disease and Asthma patients, providing a unique alternative method to clear mucus, exercise the lungs, whilst measuring real time positive expiratory lung pressures, peak flow and performance. Our TTT prototype measures expiratory air pressure, controlling musical therapy games and records analytic data to a dedicated app, which can be viewed by patients and shared with parents and clinicians. The platform enables patients to take ownership, evidence responsibility of their daily therapy and readings. Building the bridge between home and hospital care could impact upon compliance with peer reviews (page 18 https://www.nice.org.uk/guidance/qs168/documents/briefing-paper.) We hope that the collection and viewing of lung pressure/peak flow data will be an indicator of stable, deteriorated, or improved lung health. It could act as a warning indicator to seek clinical advice earlier than routine review appointments or when symptoms have increased. We aim to address the noncompliance and fatigue using current ACT/ peak flow devices by 'gamifying' the TTT (similar to Guitar Hero ), using digital platforms for different age groups of patients, respiratory diseases with differing severity of symptoms and an online community for the competitive or inquisitive. The TTT collects lung pressure/air flow data in an analytic app accessible to patients, parents and clinicians and could be deployed directly to patients with an online training facility. The contact parts of the TTT are designed to be fully sterilised after each use. One way air valves and easy-clean waterproof pressure sensors address typical infection control issues of current ACT devices. CF and COPD patients are extremely susceptible to lung infection. Proof of device infection control will be central for adoption by patients and clinicians. Confirmed PPI activities with the Cystic Fibrosis Trust, Asthma UK and Royal Brompton Hospital COPD team will be key to provide valuable lived experience and feedback, steering the creative and design teams to hone the TTT to be effective. The TTT will have reached TRL3 and we will file a PCT patent application by December 2020. Tutti Toot Ltd will own all new intellectual property arising during the project. The TTT is likely to be a medical device Class IIa, requiring conformity assessment and CE marking. A project with Great Ormond Street Hospital (May 2019) found that expiratory pressures generated while playing wind and brass musical instruments were similar to, or higher than, those targeted by people with Cystic Fibrosis when using Airway Clearance Treatment devices , providing proof of concept for the development of the TTT.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;5.3 MEDICAL DEVICES
Health categories: RESPIRATORY;CONGENITAL DISORDERS