Ginette Phippen DClinP MRCSLT Paul Grew MIMP amp Mark Richards MIMP The Spires Cleft Centre Oxford amp Salisbury Salisbury Oral amp Maxillofacial Lab ID: 560953
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Slide1
The NOSI™ : an innovative prosthetic treatment option for nasal speech associated with velopharyngeal dysfunction.
Ginette Phippen DClinP, MRCSLT, Paul Grew MIMP & Mark Richards MIMPThe Spires Cleft Centre (Oxford & Salisbury)Salisbury Oral & Maxillofacial Lab
Salisbury NHS Foundation TrustSlide2
Causes of VPD (& nasal speech)
Structural Mechanical Neurogenic Mislearning
The Spires Cleft Centre, Oxford & SalisburySlide3
Treatment optionsSurgery (+/- speech therapy)Clear structural defectSpeech therapyMislearned/compensatory sounds
ProstheticsSurgery contraindicatedPrevious unsuccessful surgeryNo intervention
The Spires Cleft Centre, Oxford & SalisburySlide4
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 & SalisburySlide5
Development processFrom this…… To this……
The Spires Cleft Centre, Oxford & SalisburySlide6
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 & SalisburySlide7
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 & SalisburySlide8
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
Support from Innovation Lead
Evaluating acceptability and function
Progressing from prototype to low volume manufacture
Phase 1
The Spires Cleft Centre, Oxford & SalisburySlide9
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 & SalisburySlide10
Prototype field testingQuestion:Is the NOSI™ acceptable and functional for individuals with nasal speech associated with VPD?
The Spires Cleft Centre, Oxford & SalisburySlide11
Field testing
The Spires Cleft Centre, Oxford & SalisburySlide12
Evaluating acceptability
The Spires Cleft Centre, Oxford & Salisbury
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
?
Yes
Sometimes
No
H
ave
you
used it…. at home
?
at
school
?
on the phone
?
3.
Do you like how the
NOSI looks
?
Yes
Not sure
No
4.
Would you
tell another child
/young person
to try the NOSI?
Yes
Maybe
No
Is there a
ny
thi
ng else you want to tell us about the NOSI
?
Slide13
Evaluating effect on speechGOS.SP.ASS Perceptual rating of resonance and audible nasal emission? Nasometry
Patient reported effect (descriptive)The Spires Cleft Centre, Oxford & SalisburySlide14
Patient
Age
Diagnosis
OX or SALS
Outcome
Status
A
21
TBI
OX
M NOSI trial at home & speech therapy
In use
B
19
TBI
OX
M NOSI trial at home & speech therapy
In use
C
13
22q11ds
OX
M NOSI for use in speech therapy at school
In use
D
51
CVA
OX
M NOSI trial at home & speech therapy
In use
E
31
Cleft Palate
OX
M NOSI trial at home
In use
F
14
Cleft Palate
OX
M NOSI trial at home & speech therapy
Waiting
G
6.9
Non-cleft VPD
OX
X-Small NOSI
Waiting
H
10
Congenital Myopathy
OX
Bespoke NOSI, one x-small nostril
Waiting
I
10
22q11ds
OX
X-Small NOSI
Waiting
J
60
Post-surg VPD
SALS
L NOSI and palatal obturator
Waiting
K
65
Post-surg VPD
SALS
L NOSI
Waiting
L
8
Cleft Palate
SALS
S NOSI
Waiting
M
28
TBI
OX
M NOSI
Discontinued
N
10
NF1
SALS
Bespoke NOSI trial at home
Discontinued
O
4.8
Worster Drought
SALS
On hold
Discontinued
P
4.11
Non-cleft VPD
SALS
S NOSI
Discontinued
Q
52
Non-cleft VPD
SALS
Bespoke NOSI trial at home
Discontinued
R
19
Worster Drought
SALS
L NOSI trial at home
Discontinued
S
49
CVA
SALS
L NOSI trial at home
Discontinued
The Spires Cleft Centre, Oxford & SalisburySlide15
The Spires Cleft Centre, Oxford & Salisbury
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
TBI
OX
M NOSI trial at home & speech therapy
hypernasality
speech effort
C
13
22q11ds
OX
M NOSI for speech therapy at school
Facilitated oral consonant placement
D
51
CVA
OX
M NOSI trial at home & speech therapy
hypernasality
speech effort
E
31
Cleft Palate
OX
M NOSI trial at home
audible nasal
emission
In UseSlide16
The Spires Cleft Centre, Oxford & Salisbury
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
OX
XS NOSI
Facilitated oral consonant placement
H
10
Congenital Myopathy
OX
Bespoke NOSI, one x-small nostril
Speech effort
I
10
22q11ds
OX
XS NOSI
?????
J
60
Post-surg VPD
SALS
L NOSI and palatal obturator
hypernasality
ANE
K
65
Post-surg VPD
SALS
L NOSI
hypernasality
ANE
L
8
Cleft Palate
SALS
S NOSI
hypernasality
ANE
WaitingSlide17
The Spires Cleft Centre, Oxford & Salisbury
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
SALS
On hold
Resistant to introduction
Try later
P
8
Non-cleft VPD
SALS
S NOSI
Candidate for palatal prosthesis
Q
52
Non-cleft VPD
SALS
Bespoke NOSI trial at home
Candidate for surgery
R
19
Worster Drought
SALS
L NOSI trial at home
Unhappy with appearance
S
49
CVA
SALS
L NOSI trial at home
Unhappy with appearance
DiscontinuedSlide18
Next steps?The Spires Cleft Centre, Oxford & SalisburySlide19
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 & SalisburySlide20
Prototype 2 The Spires Cleft Centre, Oxford & SalisburySlide21
Thank youFor more information please contact: Ginette Phippen
gphippen@nhs.net01722 345571
REFERENCES
Suwaki, M., Nanba, K., Ito, E., Kumakura, I., Minagi, S. (2008) The effect of nasal speakingvalve on the speech under experimental
incompetence condition. Journal of Oral Rehabilitation, May, 35/5, 361-9Hakel, 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.
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The Spires Cleft Centre, Oxford & Salisbury