The NOSI™ : an innovative prosthetic treatment option for nasal speech associated with velopharyngeal dysfunction. Ginette Phippen DClinP, MRCSLT, Paul Grew MIMP & Mark Richards MIMP The Spires Cleft Centre (Oxford & Salisbury) Salisbury Oral & Maxillofacial Lab Salisbury NHS Foundation Trust

Causes of VPD (& nasal speech) Structural Mechanical Neurogenic Mislearning The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Treatment options Surgery (+/- speech therapy) Clear structural defect Speech therapy Mislearned/compensatory sounds Prosthetics Surgery contraindicated Previous unsuccessful surgery No intervention The Spires Cleft Centre, Oxford & Salisbury

Non-surgical interventions for nasal speech? Palatal prosthetics is an option for some but requires a high level of commitment and resources. Could a nasal obturator offer an immediate, acceptable and low burden option for some patients? The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Development process From this…… To this…… The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury The Idea: Phase 1 (2014-15) Suwaki et al (2008)case study: nasal speaking valve Literature search: 1additional case study; Hakel et al 2004, one-way valve Product search – nasal filters Innovative valve design by maxillofacial technicians at Salisbury District Hospital The Spires Cleft Centre, Oxford & Salisbury

Developing the idea – Phase 1 (2014-15) Trademark application/design rights/patenting 3d printing Prosthesis prototypes Advice from Trust Innovation Lead Support & Funding from Spires Board Poster CFSGBI conference (April 2014) Contact with medical device manufacturers The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Phase 1 Progress Challenges Positive response to preliminary development from patients and specialist centres Valuable feedback from patients to inform design Support from Innovation Lead Funding from Spires Charitable Fund for development Interest from medical device manufacturers Making progress with development in a busy clinical service Provision of replacement devices Evaluating acceptability and function Progressing from prototype to low volume manufacture The Spires Cleft Centre, Oxford & Salisbury

Developing the idea – Phase 2 (2015-16) Field testing with 19 patients; including assessment of acceptability and effect on speech UK cleft centres signed up to test with patients….. Small number of devices made at SDH Potential manufacturer/commercial partner identified The Spires Cleft Centre, Oxford & Salisbury

Prototype field testing Question: Is the NOSI™ acceptable and functional for individuals with nasal speech associated with VPD? The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Field testing The Spires Cleft Centre, Oxford & Salisbury

Evaluating acceptability 1. Does your speech sound different when you use the NOSI ? Yes Don’t know No H ow does it sound to you? _________________________________________________________________ 2. Are you happy to use the NOSI Sometimes ave you used it…. at home at school on the phone 3. Do you like how the NOSI looks Not sure 4. Would you tell another child /young person to try the NOSI? Maybe Is there a ny thi ng else you want to tell us about the NOSI The Spires Cleft Centre, Oxford & Salisbury

Evaluating effect on speech GOS.SP.ASS Perceptual rating of resonance and audible nasal emission ? Nasometry Patient reported effect (descriptive) The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Patient Age Diagnosis OX or SALS Outcome Status A 21 TBI OX M NOSI trial at home & speech therapy In use B 19 C 13 22q11ds M NOSI for use in speech therapy at school D 51 CVA E 31 Cleft Palate M NOSI trial at home F 14 Waiting G 6.9 Non-cleft VPD X-Small NOSI H 10 Congenital Myopathy Bespoke NOSI, one x-small nostril I J 60 Post-surg VPD SALS L NOSI and palatal obturator K 65 L NOSI L 8 S NOSI M 28 M NOSI Discontinued N NF1 Bespoke NOSI trial at home O 4.8 Worster Drought On hold P 4.11 Non-cleft VPD Q 52 R L NOSI trial at home Discontinued   S 49 The Spires Cleft Centre, Oxford & Salisbury

Subjective Evaluation In Use Pt Age Diagnosis OX or SALS Outcome Subjective Evaluation A 21 TBI OX M NOSI trial at home & speech therapy speech effort ? facilitated voice B 19 hypernasality speech effort C 13 22q11ds M NOSI for speech therapy at school Facilitated oral consonant placement D 51 CVA E 31 Cleft Palate M NOSI trial at home audible nasal emission The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Waiting Pt Age Diagnosis OX or SALS Outcome Evaluation (interim) F 14 Cleft Palate OX M NOSI trial at home & speech therapy  hypernasality Facilitated oral consonant placement G 6.9 Non-cleft VPD XS NOSI H 10 Congenital Myopathy Bespoke NOSI, one x-small nostril  Speech effort I 22q11ds ????? J 60 Post-surg VPD SALS L NOSI and palatal obturator hypernasality ANE K 65 L NOSI L 8 S NOSI The Spires Cleft Centre, Oxford & Salisbury

Discontinued Patient Age Diagnosis OX or SALS Outcome Evaluation M 28 TBI OX M NOSI Not independent Robotic surgery N 10 NF1 SALS Bespoke NOSI trial at home Low impact of VPI O 4.8 Worster Drought On hold Resistant to introduction Try later P 8 Non-cleft VPD S NOSI Candidate for palatal prosthesis Q 52 Candidate for surgery R 19 L NOSI trial at home Unhappy with appearance S 49 CVA The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Next steps? The Spires Cleft Centre, Oxford & Salisbury

Development process – Phase 2 (2016) Medical technology company discussions Prototype 2 prosthesis completed (Injection moulding) Further field testing with 12 patients and other cleft centres/SLT depts Class 1 Medical Device/CE marking Commercialisation process Formal evaluation The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Prototype 2 The Spires Cleft Centre, Oxford & Salisbury

The Spires Cleft Centre, Oxford & Salisbury Thank you REFERENCES Suwaki, M., Nanba, K., Ito, E., Kumakura, I., Minagi, S. (2008) The effect of nasal speaking valve on the speech under experimental incompetence condition. Journal of Oral Rehabilitation, May, 35/5, 361-9 Hakel, M., Beukelman, D,R., Fager, S., Green, J.,Marshall, J. (2004) Nasal obturator for velopharyngeal dysfunction in dysarthria: Technical report on a one-way valve. Journal of Medical Speech-Language Pathology, December,12/4, 155-9. Sell, D., Harding, A. & Grunwell, P. (1999). GOS.SP.ASS'98: an assessment for speech disorders associated with cleft palate and / or velopharyngeal dysfunction (revised). Int. J. Language & Communication Disorders, 34(1), 17-33. For more information please contact: Ginette Phippen gphippen@nhs.net 01722 345571 ©NOSI™ 2014 WWW.SPIRESCLEFTCENTRE.NHS.UK The Spires Cleft Centre, Oxford & Salisbury