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

Informazioni relative al progetto

Respiratory Analyzer

ID dell’accordo di sovvenzione: 683740

DOI

10.3030/683740

Progetto chiuso

Data della firma CE 29 Maggio 2015

Data di avvio 1 Giugno 2015

Data di completamento 31 Ottobre 2015

Finanziato da

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

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

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)

Periodo di rendicontazione: 2015-06-01 al 2015-10-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.

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