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Grazie per aver visitato la nostra biblioteca delle prove! Per noi è importante che possiate trovare le prove a sostegno del nostro prodotto e delle affermazioni fatte su di esso. Di seguito è riportata la raccolta degli studi che hanno informato lo sviluppo dell'applicazione e i messaggi di marketing. Se avete domande o dubbi, contattate info@silentcloud.com.

SilentCloud è un software medico che offre terapie comprovate per la gestione dell'acufene.

Supporting Evidence for Cognitive Behavioral Therapy (CBT)

  1. Cima, R. F., Maes, I. H., Joore, M. A., Scheyen, D. J., El Refaie, A., Baguley, D. M., ... & Vlaeyen, J. W. (2012). Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. The Lancet, 379(9830), 1951-1959.
  2. Weise, C., Kleinstäuber, M., & Andersson, G. (2016). Internet-delivered cognitive-behavior therapy for tinnitus: a randomized controlled trial. Psychosomatic Medicine, 78(4), 501-510.;
  3. Hesser, H., Gustafsson, T., Lundén, C., Henrikson, O., Fattahi, K., Johnsson, E., ... & Andersson, G. (2012). A randomized controlled trial of Internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. Journal of Consulting and Clinical Psychology, 80(4), 649.
  4. Jasper, K., Weise, C., Conrad, I., Andersson, G., Hiller, W., & Kleinstaeuber, M. (2014). Internet-based guided self-help versus group cognitive behavioral therapy for chronic tinnitus: a randomized controlled trial. Psychotherapy and Psychosomatics, 83(4), 234-246.
  5. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr, E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head and Neck Surgery, 151(2_suppl), S1-S40.
  6. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019). A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment. HNO, 67(Suppl 1), 10-42

Supporting Evidence for Sound Therapy

  1. 1) Cima, R. F., Maes, I. H., Joore, M. A., Scheyen, D. J., El Refaie, A., Baguley, D. M., ... &
    Vlaeyen, J. W. (2012). Specialised treatment based on cognitive behaviour therapy versus
    usual care for tinnitus: a randomised controlled trial. The Lancet, 379(9830), 1951-1959.
  2. Theodoroff, S. M., McMillan, G. P., Zaugg, T. L., Cheslock, M., Roberts, C., & Henry, J. A.
    (2017). Randomized controlled trial of a novel device for tinnitus sound therapy during
    sleep. American Journal of Audiology, 26(4), 543-554.
  3. Theodoroff, S. M., McMillan, G. P., Schmidt, C. J., Dann, S. M., Hauptmann, C., Goodworth,
    M. C., ... & Henry, J. A. (2021). Randomised controlled trial of interventions for bothersome
    tinnitus: Desyncra TM versus cognitive behavioural therapy. International Journal of Audiology,
    1-10.
  4. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.

SilentCloud offers recommended therapies

  1. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.
  2. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO, 67(Suppl 1), 10-42.

Supporting Evidence for cognitive behavioral therapy (our CBT is based on validated protocols, worked out with experts in the field) / education and counseling

  1. Cima, R. F., Maes, I. H., Joore, M. A., Scheyen, D. J., El Refaie, A., Baguley, D. M., ... &
    Vlaeyen, J. W. (2012). Specialised treatment based on cognitive behaviour therapy versus
    usual care for tinnitus: a randomised controlled trial. The Lancet, 379(9830), 1951-1959.
  2. Weise, C., Kleinstäuber, M., & Andersson, G. (2016). Internet-delivered cognitive-behavior
    therapy for tinnitus: a randomized controlled trial. Psychosomatic Medicine, 78(4), 501-510.;
  3. Hesser, H., Gustafsson, T., Lundén, C., Henrikson, O., Fattahi, K., Johnsson, E., ... &
    Andersson, G. (2012). A randomized controlled trial of Internet-delivered cognitive behavior
    therapy and acceptance and commitment therapy in the treatment of tinnitus. Journal of
    Consulting and Clinical Psychology, 80(4), 649.
  4. Jasper, K., Weise, C., Conrad, I., Andersson, G., Hiller, W., & Kleinstaeuber, M. (2014).
    Internet-based guided self-help versus group cognitive behavioral therapy for chronic
    tinnitus: a randomized controlled trial. Psychotherapy and Psychosomatics, 83(4), 234-246.
  5. Kaldo, V., Haak, T., Buhrman, M., Alfonsson, S., Larsen, H.-C., & Andersson, G. (2013).
    Internet-Based Cognitive Behaviour Therapy for Tinnitus Patients Delivered in a Regular
    Clinical Setting: Outcome and Analysis of Treatment Dropout. Cognitive behaviour therapy,
    42(2), 146-158. doi:10.1080/16506073.2013.769622
  6. Kröner-Herwig, B., Jäger, B., & Goebel, G. (2010). Tinnitus: Kognitiv-
    verhaltenstherapeutisches Behandlungsmanual. Mit Online-Materialien. Beltz.
  7. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO. doi:10.1007/s00106-019-0633-7guideline NG155, N. (2020). Tinnitus: assessment and
    management. Methods.
  8. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.
  9. Scherer, R. W., Formby, C., & Tinnitus Retraining Therapy Trial Research Group. (2019).
    Effect of tinnitus retraining therapy vs standard of care on tinnitus-related quality of life: a
    randomized clinical trial. JAMA Otolaryngology–Head & Neck Surgery, 145(7), 597-608.

Cognitive Behavioral Therapy (CBT) is the current gold standard for tinnitus management 1,2 reporting 39% reduction on THI 3 . Existing CBT protocols have been tailored for online based CBT (iCBT) and have the advantage of not requiring clinician and patient interaction. iCBT has been shown to be similarly effective as more traditional group CBT (34% vs 37.5%, difference was not significant).

  1. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.
  2. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO, 67(Suppl 1), 10-42.
  3. Weise, C., Kleinstäuber, M., & Andersson, G. (2016). Internet-Delivered Cognitive-Behavior
    Therapy for Tinnitus: A Randomized Controlled Trial. Psychosomatic Medicine, 78(4), 501-
    510. doi:10.1097/psy.0000000000000310
  4. Hesser, H., Gustafsson, T., Lundén, C., Henrikson, O., Fattahi, K., Johnsson, E., . . . Kaldo, V.
    (2012). A randomized controlled trial of internet-delivered cognitive behavior therapy and
    acceptance and commitment therapy in the treatment of tinnitus. Journal of Consulting and
    Clinical Psychology, 80(4), 649.
  5. Kaldo, V., Haak, T., Buhrman, M., Alfonsson, S., Larsen, H.-C., & Andersson, G. (2013).
    Internet-Based Cognitive Behaviour Therapy for Tinnitus Patients Delivered in a Regular
    Clinical Setting: Outcome and Analysis of Treatment Dropout. Cognitive behaviour therapy,
    42(2), 146-158. doi:10.1080/16506073.2013.769622
  6. Jasper, K., Weise, C., Conrad, I., Andersson, G., Hiller, W., & Kleinstäuber, M. (2014).
    Internet-Based Guided Self-Help versus Group Cognitive Behavioral Therapy for Chronic
    Tinnitus: A Randomized Controlled Trial. Psychotherapy and Psychosomatics, 83(4), 234-246.
    doi:10.1159/000360705

Supporting Evidence for Tailored Sound Therapy: The sounds in this approach consist of tailored noise that can be used with headphones or hearing aids (depending on the tinnitus frequency). This type of sound therapy for tinnitus has shown a reduction in THI scores by 27.9% in subjects significantly impacted by their tinnitus.

  1. Henry, J. A., Schechter, M. A., Zaugg, T. L., Griest, S., Jastreboff, P. J., Vernon, J. A., Lyons, K.
    S. (2006). Outcomes of Clinical Trial: Tinnitus Masking versus Tinnitus Retraining Therapy.
    Journal of the American Academy of Audiology, 17, 104-132.

Further references for sound therapy

  1. Theodoroff, S. M., McMillan, G. P., Zaugg, T. L., Cheslock, M., Roberts, C., & Henry, J. A.
    (2017). Randomized controlled trial of a novel device for tinnitus sound therapy during
    sleep. American Journal of Audiology, 26(4), 543-554.
  2. Theodoroff, S. M., McMillan, G. P., Schmidt, C. J., Dann, S. M., Hauptmann, C., Goodworth,
    M. C., ... & Henry, J. A. (2021). Randomised controlled trial of interventions for bothersome
    tinnitus: DesyncraTM versus cognitive behavioural therapy. International Journal of
    Audiology, 1-10.
  3. Cima, R. F., Maes, I. H., Joore, M. A., Scheyen, D. J., El Refaie, A., Baguley, D. M., ... &
    Vlaeyen, J. W. (2012). Specialised treatment based on cognitive behaviour therapy versus
    usual care for tinnitus: a randomised controlled trial. The Lancet, 379(9830), 1951-1959.
  4. Sereda, M., Xia, J., El Refaie, A., Hall, D. A., & Hoare, D. J. (2018). Sound therapy (using
    amplification devices and/or sound generators) for tinnitus. Cochrane Database of
    Systematic Reviews, (12).
     
  5. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.

Supporting Evidence for proprietary Neuromodulation: In this neuromodulation approach, a very specific sound therapy is supplied through headphones on a daily dosage basis. Tailored Tonal Sound Therapy has shown an improvement of 28.8% on the Tinnitus Questionnaire (after 12 weeks) and a 52.6% reduction of loudness visual analog scale after 12 weeks of stimulation.

  1. Tass, P. A., Adamchic, I., Freund, H.-J., Stackelberg, T. v., & Hauptmann, C. (2012).
    Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restorative
    Neurology and Neuroscience, 30, 137-159.

    Further references:
  2. Theodoroff, S. M., McMillan, G. P., Schmidt, C. J., Dann, S. M., Hauptmann, C., Goodworth,
    M. C., ... & Henry, J. A. (2021). Randomised controlled trial of interventions for bothersome
    tinnitus: DesyncraTM versus cognitive behavioural therapy. International Journal of
    Audiology, 1-10.
  3. Hauptmann, C., Ströbel, A., Williams, M., Patel, N., Wurzer, H., von Stackelberg, T., ... &
    Tass, P. A. (2015). Acoustic coordinated reset neuromodulation in a real life patient
    population with chronic tonal tinnitus. BioMed Research International, 2015.

SilentCloud offers a unique combination of clinically validated tinnitus assessment

  1. Zeman, F., Koller, M., Figueiredo, R., Aazevedo, A., Rates, M., Coelho, C., ... & Landgrebe,
    M. (2011). Tinnitus handicap inventory for evaluating treatment effects: which changes are
    clinically relevant? Otolaryngology--Head and Neck Surgery, 145(2), 282-287.
  2. Meikle, M. B., Henry, J. A., Griest, S. E., Stewart, B. J., Abrams, H. B., McArdle, R., ... &
    Vernon, J. A. (2012). The tinnitus functional index: development of a new clinical measure for
    chronic, intrusive tinnitus. Ear and Hearing, 33(2), 153-176.
  3. Hauptmann, C., Wegener, A., Poppe, H., Williams, M., Popelka, G., & Tass, P. A. (2016).
    Validation of a mobile device for acoustic coordinated reset neuromodulation tinnitus
    therapy. Journal of the American Academy of Audiology, 27(09), 720-731.

By offering education, counseling, and a specific sound therapy using pink noise, SilentCloud can support the needs of tinnitus patients with hyperacusis, a known comorbidity of tinnitus

  1. Noreña, A. J., & Chery-Croze, S. (2007). Enriched acoustic environment rescales auditory
    sensitivity. Neuroreport, 18(12), 1251-1255.
  2. Vernon, J. A. (1987). Pathophysiology of tinnitus: a special case--hyperacusis and a proposed
    treatment. The American Journal of Otology, 8(3), 201-202.
  3. Lindsey, H. (2014). Help for Hyperacusis: Treatments Turn Down Discomfort. The Hearing
    Journal, 67(8), 22-24

Tinnitus Prevalence is 10-15% of the world population / ~20% of tinnitus sufferers need clinical intervention

  1. Tunkel, D. E., Bauer, C. A., Sun, G. H., Rosenfeld, R. M., Chandrasekhar, S. S., Cunningham Jr,
    E. R., ... & Whamond, E. J. (2014). Clinical practice guideline: tinnitus. Otolaryngology–Head
    and Neck Surgery, 151(2_suppl), S1-S40.
  2. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO. doi:10.1007/ s00106-019-0633-7guideline NG155, N. (2020). Tinnitus: assessment and
    management. Methods.
  3. Baguley, D., McFerran, D., & Hall, D. (2013). Tinnitus. The Lancet, 382, 1600-1607.
    doi:10.1016/S0140-6736(13)60142-7
  4. Jarach, C. M., Lugo, A., Scala, M., van den Brandt, P. A., Cederroth, C. R., Odone, A., ... &
    Gallus, S. (2022). Global Prevalence and Incidence of Tinnitus: A Systematic Review and
    Meta-analysis. JAMA neurology.

~80% of people experiencing tinnitus have hearing loss

  1. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO. doi:10.1007/ s00106-019-0633-7guideline NG155, N. (2020). Tinnitus: assessment and
    management. Methods.
  2. Baguley, D., McFerran, D., & Hall, D. (2013). Tinnitus. The Lancet, 382, 1600-1607.
    doi:10.1016/S0140-6736(13)60142-7
  3. Sereda, M., Xia, J., El Refaie, A., Hall, D. A., & Hoare, D. J. (2018). Sound therapy (using
    amplification devices and/or sound generators) for tinnitus. Cochrane Database of
    Systematic Reviews, (12).8

Tinnitus is associated with hearing loss, noise exposure, stress, aging

  1. Cima, R. F. F., Mazurek, B., Haider, H., Kikidis, D., Lapira, A., Noreña, A., & Hoare, D. J. (2019).
    A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment.
    HNO. doi:10.1007/ s00106-019-0633-7guideline NG155, N. (2020). Tinnitus: assessment and
    management. Methods.
  2. Shore, S. E., Roberts, L. E., & Langguth, B. (2016). Maladaptive plasticity in tinnitus—triggers,
    mechanisms and treatment. Nature Reviews Neurology, 12(3), 150-160.
  3. Baguley, D., McFerran, D., & Hall, D. (2013). Tinnitus. The Lancet, 382, 1600-1607.
    doi:10.1016/S0140-6736(13)60142-7