Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
The Role of Compliance and Cost in Regulating the Effectiveness of Notched Sound Therapy Phone Applications for Tinnitus Relief: Updated Analysis of a Prospective Randomized Control Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Sturm Hannah, Adamovich-Zeitlin Richard, Pelosi Stanley, Mulloly Virginia, Svrakic Maja
Аннотация
BACKGROUND: Notched sound therapy (NST) is a mobile application that has been shown to provide tinnitus relief by reducing dysfunctional auditory cortex reorganization. This study aimed to evaluate the role of compliance with notched sound therapy (NST) on the effectiveness of reducing tinnitus symptoms.
METHODS: A prospective randomized control trial was performed in patients older than or equal to 18 years at a tertiary referral center. Patients were randomized at enrollment to either the NST group and given a free subscription to the NST mobile application or the standard of care (SOC) group. Continued enrollment in the study, NST use, and tinnitus handicap index (THI) were evaluated at 6 weeks, 3 months, 6 months, and 12 months in the NST versus SOC group and in NST users versus non-users.
RESULTS: Patients in the NST group were 2.2 times more likely to use NST at 6-week follow-up compared with the SOC group (70% vs. 32%, P =0.020). Initial THI score, age, and tinnitus frequency and loudness did not significantly impact follow-up rates or NST use. Assignment to the NST treatment group was associated with a significantly increased reduction in THI compared with the SOC group (β: -10.02, 95% CI: -18.20, -1.83, P =0.017). However, NST use was not associated with any significant changes in THI compared with NST non-users.
CONCLUSIONS: Overall, reduced cost of NST treatment was associated with greater tinnitus relief; however, compliance with treatment was not significantly associated with THI changes. Therefore, these changes may be explained by psychological factors reinforcing patient empowerment, perceived support, and accountability.
METHODS: A prospective randomized control trial was performed in patients older than or equal to 18 years at a tertiary referral center. Patients were randomized at enrollment to either the NST group and given a free subscription to the NST mobile application or the standard of care (SOC) group. Continued enrollment in the study, NST use, and tinnitus handicap index (THI) were evaluated at 6 weeks, 3 months, 6 months, and 12 months in the NST versus SOC group and in NST users versus non-users.
RESULTS: Patients in the NST group were 2.2 times more likely to use NST at 6-week follow-up compared with the SOC group (70% vs. 32%, P =0.020). Initial THI score, age, and tinnitus frequency and loudness did not significantly impact follow-up rates or NST use. Assignment to the NST treatment group was associated with a significantly increased reduction in THI compared with the SOC group (β: -10.02, 95% CI: -18.20, -1.83, P =0.017). However, NST use was not associated with any significant changes in THI compared with NST non-users.
CONCLUSIONS: Overall, reduced cost of NST treatment was associated with greater tinnitus relief; however, compliance with treatment was not significantly associated with THI changes. Therefore, these changes may be explained by psychological factors reinforcing patient empowerment, perceived support, and accountability.