TY - JOUR
T1 - Randomized controlled trial of a novel device for tinnitus sound therapy during sleep
AU - Theodoroff, Sarah M.
AU - McMillan, Garnett P.
AU - Zaugg, Tara L.
AU - Cheslock, Megan
AU - Roberts, Chan
AU - Henry, James A.
N1 - Funding Information:
Disclosure: This research was funded by the Baker Group, LLP, who manufactured the Levo System device (Portland VA Research Foundation #387004) and by the Department of Veterans Affairs, Rehabilitation Research & Development (RR&D) Service (C9247S and C9230C) at the VA Portland Health Care System in Portland, Oregon. Once agreement was reached as to study design, all study procedures and data analyses were conducted independent of any company influence.
Funding Information:
This research was funded by the Baker Group, LLP, who manufactured the Levo System device (Portland VA Research Foundation 387004), and by the Department of Veterans Affairs, Rehabilitation Research & Development Service by a Program Award to the National Center for Rehabilitative Auditory Research (C9230C) and by a research career scientist award granted to Dr. James A. Henry (C9247S) at the VA Portland Health Care System in Portland, Oregon. These contents do not represent the views of the U.S. Department of Veterans Affairs, Department of Defense, or the U.S. Government.
Publisher Copyright:
© 2017 The Authors.
PY - 2017/12
Y1 - 2017/12
N2 - Purpose: The aim of this study was to determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus. Method: Sixty participants were randomized to 1 of 3 groups that used sound therapy devices during sleep that differed in their acoustic stimulus: (a) tinnitus-matched (TM), (b) noise stimulus (NS), and (c) bedside sound generator (BSG). Outcome measures were the Tinnitus Functional Index (TFI), numeric rating scale of tinnitus loudness, and tinnitus loudness match. A Bayesian hierarchical model was fit to estimate the differences in treatment efficacy among groups. Results: Average tinnitus reactions and perceptions improved across treatment groups. We are at least 87% certain that treatment with TM or NS reduces mean TFI compared to treatment with BSG, with an estimated relative efficacy of 4.5–5 points greater reduction. We are at least 95% certain that treatment with TM results in greater reduction in mean numeric rating scale (NRS) of tinnitus loudness compared to the other groups, with an estimated relative efficacy of about 0.75 points greater reduction. Conclusions: This study offers some support for greater average improvement in reactions to tinnitus with TM or NS devices compared to the BSG device. The TM group, compared to the BSG and NS groups, showed a greater reduction in ratings of tinnitus loudness on the NRS on average.
AB - Purpose: The aim of this study was to determine if a customized stimulus from the Otoharmonics Levo System reduces tinnitus perceptions and reactions for people with bothersome tinnitus. Method: Sixty participants were randomized to 1 of 3 groups that used sound therapy devices during sleep that differed in their acoustic stimulus: (a) tinnitus-matched (TM), (b) noise stimulus (NS), and (c) bedside sound generator (BSG). Outcome measures were the Tinnitus Functional Index (TFI), numeric rating scale of tinnitus loudness, and tinnitus loudness match. A Bayesian hierarchical model was fit to estimate the differences in treatment efficacy among groups. Results: Average tinnitus reactions and perceptions improved across treatment groups. We are at least 87% certain that treatment with TM or NS reduces mean TFI compared to treatment with BSG, with an estimated relative efficacy of 4.5–5 points greater reduction. We are at least 95% certain that treatment with TM results in greater reduction in mean numeric rating scale (NRS) of tinnitus loudness compared to the other groups, with an estimated relative efficacy of about 0.75 points greater reduction. Conclusions: This study offers some support for greater average improvement in reactions to tinnitus with TM or NS devices compared to the BSG device. The TM group, compared to the BSG and NS groups, showed a greater reduction in ratings of tinnitus loudness on the NRS on average.
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U2 - 10.1044/2017_AJA-17-0022
DO - 10.1044/2017_AJA-17-0022
M3 - Article
C2 - 29090311
AN - SCOPUS:85037825697
VL - 26
SP - 543
EP - 554
JO - American Journal of Audiology
JF - American Journal of Audiology
SN - 1059-0889
IS - 4
ER -