Validation of calibrated RIP (respiratory inductive plethysmography) based biomarker for diagnosis of SDB (sleep-disordered breathing) and the identification of an accessible screening solution

Project Information

Respiratory Analyzer

Grant agreement ID: 683740

DOI

10.3030/683740

Project closed

EC signature date 29 May 2015

Start date 1 June 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

NOX MEDICAL EHF
Iceland

Periodic Reporting for period 1 - Respiratory Analyzer (Validation of calibrated RIP (respiratory inductive plethysmography) based biomarker for diagnosis of SDB (sleep-disordered breathing) and the identification of an accessible screening solution)

Reporting period: 2015-06-01 to 2015-10-31

Summary of the context and overall objectives of the project

Nox Medical will validate a biomarker for Sleep disordered breathing (SDB). The Biomarker consists of calibrated RIP belt measurements, giving information about the breathing quality and sleep quality. The deliverables for the phase 1 study is a list of clinical partners from 7 different countries, results of two pilot validation studies and a business plan.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Two pilot studies were carried out on the clinical relevance of the Biomarker. The studies included a physiological validation of the Biomarker by comparing it to a gold standard invasive method of measuring respiratory effort, and a comparison of the Biomarker with clinical outcomes in teenagers. The results presented at the World Sleep conference in Istanbul showed that the Biomarker can be used as a surrogate measure of the underlying physiology and it correlates with clinical outcomes. (see image 1)
The marketing effort related to the feasibility study involved visiting conferences and exhibitions, and contacting customers worldwide during the study. The results generated in the Feasibility study inspire further clinical validation of the Biomarker.
The market research clearly identified a need in the market for the Biomarker and possible applications of the Biomarker extend far beyond sleep science. The market is waiting for a solution that can be applied to diagnose SDB both to be able to diagnose patients who suffer from SDB and are not diagnosed with current methods, and to diagnose the underlying cause of SDB in patients and target treatment to the cause. The Biomarker needs to be clinically validated to be accepted as a basis for diagnostics.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The business idea will be pursued. Nox Medical aims to change the paradigm of sleep diagnostics, allowing physicians to diagnose patients suffering from conditions linked to SDB and to diagnose the underlying cause of SDB in their patients. This will allow un-treated patient groups to get treatment and physicians to target treatment to the underlying cause of the disease.

To fully exploit the market opportunity two main tasks need to be worked on:
1) Nox Medical has applied for Phase II in the SME Instrument to finance clinical validation of the Biomarker. This will allow Nox Medical to augment current sleep diagnostics and allow sleep specialists to enhance their diagnostics capabilities to diagnose patients who cannot be diagnosed with current methods.
2) A development of a novel sleep diagnostics device and service that allows other medical professionals than sleep specialists to use sleep diagnostics as a routine diagnostics tool.

The development of this solution will mark the start of a revolution in sleep diagnostics devices.

breathing-efficiency.jpg