Periodic Reporting for period 1 - FitSleep (Fabricating Non-Invasive Temporal Interference Devices for Obstructive Sleep Apnea which Electrically activate the Hypoglossal Nerve)
Periodo di rendicontazione: 2024-05-01 al 2025-10-31
The FitSleep project emerges from a critical need to address Obstructive Sleep Apnea (OSA), a prevalent disorder affecting over a billion people globally.
OSA is characterized by episodes of reduced or absent airflow during sleep due to airway obstruction, resulting in poor sleep quality and increased risks of severe health issues such as hypertension, stroke, and depression. Current treatments, predominantly Continuous Positive Airway Pressure (CPAP) machines, offer relief but suffer from low patient compliance due to discomfort and invasiveness.
The overarching objective of FitSleep is to revolutionize OSA treatment by developing and validating a non-invasive, user-friendly device that stimulates the hypoglossal nerve to maintain airway openness during sleep. This innovative approach utilizes Temporal Interference (TI) technology, a novel form of non-invasive electrical stimulation that has shown promise in preliminary clinical applications beyond OSA, including neurological disorders.
The specific aims of the project are:
1. To Develop and Optimize the TI Device: Engineering a wearable device that can effectively deliver TI stimulation to the hypoglossal nerve without the need for surgical implantation.
2. To Conduct Comprehensive pilot studies: To validate the efficacy and safety of the FitSleep device through rigorous pilots. These trials will assess the device’s ability to reduce the Apnea-Hypopnea Index (AHI), improve sleep quality, and enhance overall patient well-being compared to baseline and traditional treatments.
3. To Facilitate Market Entry and Adoption: To navigate the regulatory landscape for approval and to develop strategies for market introduction and adoption, focusing on patient and physician education to ensure widespread acceptance and use.
FitSleep's innovative approach has the potential not only to improve health outcomes for individuals with OSA but also to enhance their quality of life by offering a more comfortable and less obtrusive treatment option. The project aligns with health priorities worldwide, emphasizing patient-centered care and leveraging cutting-edge technology to meet clinical needs. FitSleep aims to set a new standard in sleep apnea treatment, making effective therapy accessible and palatable to those in need.
OSA is characterized by episodes of reduced or absent airflow during sleep due to airway obstruction, resulting in poor sleep quality and increased risks of severe health issues such as hypertension, stroke, and depression. Current treatments, predominantly Continuous Positive Airway Pressure (CPAP) machines, offer relief but suffer from low patient compliance due to discomfort and invasiveness.
The overarching objective of FitSleep is to revolutionize OSA treatment by developing and validating a non-invasive, user-friendly device that stimulates the hypoglossal nerve to maintain airway openness during sleep. This innovative approach utilizes Temporal Interference (TI) technology, a novel form of non-invasive electrical stimulation that has shown promise in preliminary clinical applications beyond OSA, including neurological disorders.
The specific aims of the project are:
1. To Develop and Optimize the TI Device: Engineering a wearable device that can effectively deliver TI stimulation to the hypoglossal nerve without the need for surgical implantation.
2. To Conduct Comprehensive pilot studies: To validate the efficacy and safety of the FitSleep device through rigorous pilots. These trials will assess the device’s ability to reduce the Apnea-Hypopnea Index (AHI), improve sleep quality, and enhance overall patient well-being compared to baseline and traditional treatments.
3. To Facilitate Market Entry and Adoption: To navigate the regulatory landscape for approval and to develop strategies for market introduction and adoption, focusing on patient and physician education to ensure widespread acceptance and use.
FitSleep's innovative approach has the potential not only to improve health outcomes for individuals with OSA but also to enhance their quality of life by offering a more comfortable and less obtrusive treatment option. The project aligns with health priorities worldwide, emphasizing patient-centered care and leveraging cutting-edge technology to meet clinical needs. FitSleep aims to set a new standard in sleep apnea treatment, making effective therapy accessible and palatable to those in need.
Across the 18-month FitSleep action, we implemented the five planned activities and delivered the core outputs foreseen in Annex 1: (i) a miniaturized Stage I Clinical Device (SICD) for bilateral temporal-interference hypoglossal nerve stimulation, including the main electronics, user interface/enclosure, and clinical accessories (electrode patches and patient cables), supported by a fit-for-purpose QA/QMS set-up (SOPs, design history/technical file structure) and verification/validation testing appropriate for first clinical home use; (ii) bilingual clinician/participant information materials and step-by-step home-use guidance; and (iii) designed the multi-week take-home pilot with home baseline, in-lab titration, and at-home use, generating an integrated data package covering efficacy signals (AHI/oxygenation trends with expected inter-subject variability), safety/tolerability, and human-factors/usability feedback to lock down device performance specifications for the next design iteration. In parallel, we delivered the planned market-insights output (competitive landscape, target segments, willingness-to-adopt drivers and barriers), a consolidated IP/regulatory workstream (FTO/IP surveillance and filings strategy, initial regulatory pathway mapping and technical-documentation plan, and early interactions with a CE Notified Body), and a business strategy deliverable (commercialization options, development roadmap, and investor-ready summary/pitch materials) to position the innovation for follow-on funding and/or licensing.
Relative to the Description of the Action, implementation differences were limited and justified by de-risking priorities typical for PoC-to-TRL5 translation: the primary SICD and take-home clinical package proceeded as planned, while the “Series II” wireless device work (Task 1.5) was completed to a pre-engineering/design-freeze level (architecture, requirements, risk file, and supplier/manufacturing plan) but we did not progress to a fully integrated wireless 2.0 hardware build within this action, because the team prioritized incorporating take-home usability/comfort learnings and locking clinical specifications before committing to a costly redesign and additional pre-compliance testing; this shift strengthens, rather than weakens, the next step toward a commercial prototype. Pre-compliance/bench testing was used where full certification-grade testing would not be proportionate at this stage, with the standards roadmap captured in the technical documentation plan. No partial lump sum share is declared, as the action’s planned work packages were completed and all key deliverables for the PoC objectives were produced; the wireless build is treated as a planned follow-on activity beyond this action’s scope rather than an unfinished core task. Subcontracting was used only as foreseen (specialist suppliers and market analysis, and external patent/regulatory support including Notified Body interactions); no additional, unplanned subcontracting was required.
Relative to the Description of the Action, implementation differences were limited and justified by de-risking priorities typical for PoC-to-TRL5 translation: the primary SICD and take-home clinical package proceeded as planned, while the “Series II” wireless device work (Task 1.5) was completed to a pre-engineering/design-freeze level (architecture, requirements, risk file, and supplier/manufacturing plan) but we did not progress to a fully integrated wireless 2.0 hardware build within this action, because the team prioritized incorporating take-home usability/comfort learnings and locking clinical specifications before committing to a costly redesign and additional pre-compliance testing; this shift strengthens, rather than weakens, the next step toward a commercial prototype. Pre-compliance/bench testing was used where full certification-grade testing would not be proportionate at this stage, with the standards roadmap captured in the technical documentation plan. No partial lump sum share is declared, as the action’s planned work packages were completed and all key deliverables for the PoC objectives were produced; the wireless build is treated as a planned follow-on activity beyond this action’s scope rather than an unfinished core task. Subcontracting was used only as foreseen (specialist suppliers and market analysis, and external patent/regulatory support including Notified Body interactions); no additional, unplanned subcontracting was required.
The wireless build is treated as a planned follow-on activity beyond this action’s scope rather than an unfinished core task. More research is still needed.