Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 543-554 |
| Number of pages | 12 |
| Journal | American Journal of Audiology |
| Volume | 26 |
| Issue number | 4 |
| DOIs | |
| State | Published - Dec 1 2017 |
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ASJC Scopus subject areas
- Speech and Hearing
Cite this
Randomized controlled trial of a novel device for tinnitus sound therapy during sleep. / Theodoroff, Sarah; McMillan, Garnett P.; Zaugg, Tara L.; Cheslock, Megan; Roberts, Chan; Henry, James.
In: American Journal of Audiology, Vol. 26, No. 4, 01.12.2017, p. 543-554.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Randomized controlled trial of a novel device for tinnitus sound therapy during sleep
AU - Theodoroff, Sarah
AU - McMillan, Garnett P.
AU - Zaugg, Tara L.
AU - Cheslock, Megan
AU - Roberts, Chan
AU - Henry, James
PY - 2017/12/1
Y1 - 2017/12/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85037825697&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85037825697&partnerID=8YFLogxK
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 -