Otoharmonics, desde la idea al mercado Un ejemplo reciente de desarrollo biomédico nacional. Marzo 2017
2016 Se aprueban 2 patentes en USPTO y se levantan en EU, Canadá, India, China, Corea del Sur Japón y Australia LEVO sale al mercado en USA y Canadá Se inician contactos con Grupo GAES (España) para distribución en Latinoamérica
2017 LEVO sale al mercado en UK En proceso de salir al mercado en EU, China, Japón y Corea del Sur
SOUND STIMULATION DURING SLEEP A new therapeutic approach for tinnitus Daniel Drexler MD, Mg Sc. Centro de Tinnitus Montevideo Uruguay
Idiopathic Tinnitus physiopathogeny (Jastreboff, 1990). input deficit No sound stimulation neural plasticity phantom sensation Over-stimulation Unknowns
Specific Sensory afferents Circadian rhythms Sensory neuron Other influences Efferent system Ultradian rhythms
Tinnitus Auditory Epilepsy? Mecanismos neurais envolvidos nas convulções audiogênicas em ratos albinos Prof Norberto García Cairasco (USP Rib. Preto)
Why acoustic stimulation???? most forms of tinnitus are caused by functional changes; thus, it should be possible to reverse them by proper sound treatment
Control Previous acoustic stimulation 1KHz 81 db 24 days
2005 14 cats exposed to acoustic trauma Group 1 sound deprived ambient (SDA) Group 2 enriched acosutic enviroment (EAE) Stimulus with multiple high frecuency tones Evaluation Audiological evaluation Tonotopic reorganization
Audiological evaluation EAE SDA
Tonotopic reorganization Control SDE EAE
ACOUSTIC STIMULATION 1. Pasive function a) Distraction/Masking Noise generators/hearing aids Vernon JA 1977 Attempts to relieve tinnitus. Journal of the American Audiology Society 1977;2:124 31. b) Habituation low intensity white noise Jastreboff 1995;McKinney 1995
ACOUSTIC STIMULATION 2. Active function a) Prevent cortical reorganization Noreña;Eggermont 2005 b) Spontaneous firing sinchronization at the auditory nerve Eggermont, 1990; Møller, 1984, 1995 c) Hiperexcitability, decrease of inhibitory sinapsis Kiang et al., 1970 d) Increase of spontaneous activity at the cochlear dorsal nucleus Brozoski, Bauer, & Caspary, 2002 e) Eferent system Hazell; 1987
Why do we mimetize? Cochlea r damage Cortical reorganization Tinnitus spectral characteristics P. Jastrebof 1990:; Eggermont, Sininger 1995
Tinnitus types Pure tone Combination of pure tones (harmonics, 8, 5, etc) White Noise BBN Cricket Combinations
Why do we mimetize??? Afferent system Efferent system
Why do we mimetize? Edge effect theory P. J. Jastreboff, 1990, Eggermont & Sininger, 1995 trigger
Tinnitus mimic Improves cortical representation at damaged frecuencies Decreases edge over-representation
Why during sleep? Auditory system processes the incoming information also during sleep. Sensory systems are a main factor in active participation in sleep processes (Velluti, 2005; Velluti and Pedemonte 2002).
Levo s treatment advantages type of acoustic stimulation acoustic stimulation during sleep
Levo System 1 doctor s audiologist s ipad 2 - patient s ipod 3 patient s customized high fidelity earphones
Wi fi connection
Levo system advantages Tinnitus mimic allows to create a customized sound Levo delivers high fidelity calibrated sound 8 hours daily stimulation period Treatment objective intensity follow up Sleep quality improvement Levo Remote
Sound intensity (ipod steps) pre post First trial 2010 25 0 1 24 20 15 10 5 0 + + 0 1 5 10 15 20 24 Weeks of sound stimulation
Second Clinical Trial February - June 2012 Preliminary Results
OBJECTIVES evaluate the efficacy and security of Levo treatment in terms of: -intensity reduction of the tinnitus -results in the psychological evaluation of tinnitus research on basic aspects of sound stimulation during sleep
Methods 12 patients with idiopatic subjectiv tinnitus Ipod touch with Levo system Customized High Fidelity earphones Counseling on device usage Sound stimulation during sleep Follow up twice a month for 3 months
Patient s selection 42 patients with tinnitus were studied 12 patients were selected Inclusion criteria Uni o bilaterla subjective idiopathic tinnitus Permanent + 6 months evolution THI score greater than 17
Patient s selection Exclusion criteria: Hearing loss greater than 50 db HTL in more than one frecuency Other Tinnitus treatments in last year Sever sleep disorders Significant depression or ansiety Psicosis
Audiometric profile
Pre Trial Evaluation Clinical ENT evaluation Clinical sleep evaluation Clinical psychological evaluation of tinnitus : Tinnitus Handicap Inventory (THI) Tinnitus Reaction Questionnaire (TRQ) Tinnitus Functional Index (TFI) Audiological tests: Impedanciometry Audiometry (0,125 to 8 khz) Logoaudiometry, Pain thresholds High frequency audiometry (8 to 16 khz) Otoacustic Emissions (DPOAE,TOAE, SOAE) MRI or CT scan Blood studies Blood cholesterol level Level of blood sugar Hemogram (Complete blood count) TSH T4 Renal function
Follow up
Results acuphenometry vs mimic less similar more similar 0 10 visual analogic scale acuphenometyry acuphenometry average 3.7 levo mimic levo mimic average7.9 p = 4.8828e-04
Results acuphenometry vs mimic Visual Analogic Scale- EVA Acuphenometry Levo Mimic
Results Tinnitus intensity reduction (db)
Results
Results Averaged Tinnitus intensity reduction 59 db 44.5 db 14.5 db Average tinnitus reduction 14.5 db
Intensity reduction 6 db reduction ½ intensity perception 14.5 db reduction more than twice intensity reduction perception 28 times power reduction
14.5
Ambient noise Levo s tinnitus reduction daily normal ambient noise
Tinnitus Awareness Tinnitus at 59 db Tinnitus at 44.5 db
Tinnitus awareness Levo Decompensated tinnitus Compensated tinnitus LIFE QUALITY
Range Results psychological evaluation of tinnitus Tinnitus Handicap Inventory Newman, Sandridge,& Jacobson, (1998) 25 questions Answers: yes (4), sometimes(2), no (0) Scale 0-100 Incapacity degree 1 16 No incapacity 17-36 Mild incapacity 37-56 Moderate incapacity 57-100 Severe incapacity
Results psychological evaluation of tinnitus Tinnitus Handicap Inventory First THI Second THI Third THI
Results psychological evaluation of tinnitus Tinnitus Handicap Inventory First THI = 47 No incapacity Moderate incapacity Second THI = 15 Third THI = 14 THI average reduction = 33 points
Results Tinnitus Reaction Questionnaire
Conclusions Second clinical trial Tinnitus Mimic is more accurate than acuphenometry Tinnitus intensity reduction. Average 14,5 db Reduction of the tinnitus psychological impact Life quality improvement
References Tinnitus treatment with sound stimulation during sleep. Pedemonte M., Drexler D., Rodio S., Geisinger D., Bianco A., Pol-Fernandes D., Bernhardt V. International Tinnitus Journal. 2010;16(1):37-43. Drexler D, López-Paullier M, Rodio S, Bianco A, Geisinger D, Pedemonte M. (2011). Sound Stimulation during sleep improves the condition of patients affected by tinnitus. International State-of-the-Science Meeting on Blast-Related Tinnitus, Northern Virginia, USA. Pedemonte M. (2011) Neurophysiologic bases of tinnitus treatment with sound stimulation during sleep. International State-of-the-Science Meeting on Blast-Related Tinnitus, Northern Virginia, USA. Pedemonte M, Drexler D, López-Paullier M, Rodio S, Bernhardt V, Bianco A, Geisinger D, Pol Fernandes D, Alvarez M. (2011) A new protocol for tinnitus treatment: sound stimulation during sleep. Clinical and electrophysiological approach. X International Tinnitus Seminar, Florianópolis. Brasil. Pedemonte M, Pol-Fernandes D, Drexler D. (2010) Sound stimulation during sleep in tinnitus patients provokes changes in the electroencephalographic waves power spectra. XX European Sleep research Societies Congress, Lisboa, Portugal. Pedemonte M, Drexler D, Rodio S, Bernhardt V. (2009) Sound stimulation during sleep: a therapeutic tool to improve tinnitus. III Congress World Association of Sleep Medicine, Sao Paulo, Brasil. Sleep Medicine, 10(2):50. López Paullier M; Drexler D; Rodio S; Pedemonte, M. (2008) Una nueva terapéutica para el tinnitus: la estimulación sonora durante el sueño. 69na. Jornadas Rioplatenses de Otorrino Laringología, Mar del Plata, Argentina. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V (2008)Tratamiento del tinnitus mediante la estimulación sonora durante el sueño.sexto Congreso Nacional de Otorrino Laringología, Punta del Este. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V. (2008)Sound Stimulation during Sleep for the Tinnitus Treatment: Trans-disciplinary Approach. XXX Congress of Association for Research in Otolaryngology, Phoenix, Arizona. Pedemonte M, Drexler D, Rodio S, Pol-Fernandes D, Bernhardt V. (2007)Sleep Sound Stimulation for Tinnitus Treatment. 2 nd Tinnitus Research Initiative Meeting, Principado de Mónaco, pp:90. Pedemonte M, Drexler D, Pol-Fernandes D, Bernhardt V. (2007) Tinnitus Treatment with Sound Stimulation during Sleep. Cycle. World Federation of Sleep Medicine Sleep Research Societies, Cairns, Australia. Sleep and Biological Rhythms 5(1): 54.
URUGUAY País pequeño Nivel educativo Sector creativo Humanismo liberal Libertad Universo digital