Title: Speech Rehabilitation from Articulator Movement (SRAM)
Funder: Department of Health and Social Care

Abstract: Activities are grouped into three areas: technical, clinical and commercial, with the following work packages. The timescale is indicated along with the lead organisation(s): Practical Control Limited (PCL), University of Hull (UoH), University of Sheffield (UoS) and Hull and East Yorkshire NHS Trust (HEY). See Gantt chart in supporting document. 1. Technical Development 1.1. Hardware development and validation 1.1.1. Miniaturisation of external sensor frame (months 1-9, PCL/UoH), to make the system more discreet and acceptable. 1.1.2. Implant instrumentation development (months 1-9, UoH/HEY). Bespoke instrumentation for magnetic implant placement will be developed, evaluated and submitted for regulatory approval. 1.1.3. Intraoral sensor system development (months 1-18, UoH/PCL) for the optimal discreet and accurate technical solution (because of the proximity of implants and sensors). Power and space budget calculations indicate that this is viable (see supporting document for mock up), but this requires significant work on design and manufacturing processes. (Milestone: month 18 &ndash; Intraoral system laboratory evaluation). 1.2. Speech processing 1.2.1. Implementation and evaluation of real time Direct Synthesis (months 1-9, UoS/UoH/PCL). Real time audio feedback is important for improving speech quality by allowing the user to learn to speak (like learning to play a musical instrument). We have demonstrated near real time Direct Synthesis for a restricted vocabulary but improvements to hardware and software are required. 1.2.2. Adaptation to different training regimes (months 1-18, UoS). Patients will follow different treatment and training pathways depending on their particular circumstances. The ideal situation is synchronous recording of audio and PMA data prior to laryngectomy but this is not always possible. Those who have already had a laryngectomy may not have a voice recording. Karaoke techniques will be developed and evaluated for voice reconstruction under these circumstances. (Deliverable: month 18 &ndash; Evaluation of training regimes). 1.2.3. Extension of vocabulary and speaking styles (months 1-24, UoS). Direct Synthesis based on PMA data has demonstrated speech reconstruction, in a voice similar to the user s, for certain vocabularies. Extension of machine learning techniques will address a wider range of vocabulary and speaking styles. 2. Clinical Development 2.1. Update stakeholder requirements (months 1-6, UoH/HEY) in the light of the enhanced system performance. This will guide further development and commercialisation priorities. (Deliverable: month 6 &ndash; Updated stakeholder priority report). 2.2. Evaluation of alternative treatment pathways (months 1-12, HEY), to assess the preferred approaches in terms of stress on the patient, ultimate system performance and treatment costs. (Deliverable: month 12 &ndash; Draft treatment guidelines). 2.3. Regulatory approval (months 9-12, 18-21, UoH/PCL). MHRA &ldquo;Notice of No Objection&rdquo;, NHS R&D and NRES REC approval of the Clinical Investigation Plan. (Milestones: month 12, 24 &ndash; Approvals in place) 2.4. Clinical Study (months 12-21 & 21-27, HEY/UoH). Studies will assess system performance using 1) external sensor frame, 2) intraoral sensor system. Initial laboratory trials will be followed by extended studies in the users home and workplace. (Deliverables: month 21 & 27 &ndash; Clinical study evaluation) 3. Commercial Development 3.1. Market Analysis (months 1-9, PCL/UoH). The size and structure of UK and international markets will be assessed and segmented on the basis of numbers of laryngectomees, current treatment practices, healthcare system characteristics, ability to pay and language characteristics. (Deliverable: month 9 &ndash; Market Analysis report) 3.2. Business Model Evaluation (months 9-18, PCL/UoH), e.g. NHS vs. Private, one-off purchase vs. rental etc, for different market segments. 3.3. Commercialisation Business Case Development (months 16-24, PCL) .This will include the costs and risks of further technical and manufacturing system development, approvals, marketing and support. (Milestone: month 24 &ndash; Preferred commercialisation plan established).

Lay abstract: Patients whose voice box must be removed as a result of throat cancer can no longer speak. Existing methods to restore speech are unsatisfactory for many patients and can result in loss of dignity and social isolation. In particular: Speech created by swallowing air, belching and forming the sound made in the swallowing tube (the oesophagus) into words, is broken, difficult to learn and embarrassing. This is called oesophageal speech. Speech created by articulating the sound made by an electrolarynx vibrating the throat is &ldquo;electronic&rdquo;, impersonal, difficult to understand and draws attention to the loss of the voice box. This is electro-laryngeal speech. A silicone valve, which connects the windpipe to the throat to divert air from the lungs into the throat, vibrates the tissues of the throat and the sound made can be used to produce fluent, but gruff speech that has a masculine quality. This is called valved speech. Unfortunately, valves typically fail after just 3 months on average due to a sticky film of yeast and bacteria and have to be changed, which is uncomfortable and distressing (and costs the NHS around &pound;10M annually). A more appealing and cost effective system of speech rehabilitation that aims to restore a more natural voice, appropriate to the user, would be welcomed by patients, doctors and health providers. We feel this is especially important for women, who at present do not have a satisfactory method of speech rehabilitation that provides a feminine voice. Our technique uses small magnetic implants and sensors to detect movement of the mouth and tongue which it converts directly into speech. In laboratory trials we have generated speech which is understandable and recognisable as the user s own voice. It is unobtrusive and the user can speak without any noticeable delay. This is a world first but the system now needs further development, improvement and evaluation. We will undertake technical developments to improve the quality and flexibility of the speech produced and make the system more discreet and user friendly. We will evaluate its performance in comparison to existing methods of speech restoration through clinical studies with patients who have had a laryngectomy and we will develop a business case to support the commercial exploitation of the system so that it can be made available to users in the UK and elsewhere.

Research activity codes: 5.3 MEDICAL DEVICES;6.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS