Randomized controlled trial of a novel device for tinnitus sound therapy during sleep

Sarah Theodoroff, Garnett P. McMillan, Tara L. Zaugg, Megan Cheslock, Chan Roberts, James Henry

Research output: Contribution to journalArticle

9 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)543-554
Number of pages12
JournalAmerican Journal of Audiology
Volume26
Issue number4
DOIs
StatePublished - Dec 1 2017

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Tinnitus
Sleep
Randomized Controlled Trials
Equipment and Supplies
Therapeutics
Noise
Acoustics

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 journalArticle

Theodoroff, Sarah ; McMillan, Garnett P. ; Zaugg, Tara L. ; Cheslock, Megan ; Roberts, Chan ; Henry, James. / Randomized controlled trial of a novel device for tinnitus sound therapy during sleep. In: American Journal of Audiology. 2017 ; Vol. 26, No. 4. pp. 543-554.
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