Evidence map›Paper›PMID 36575531›Full record

ArticleTrials2022

Efficacy of hearing aid treatment on sound perception and residual hearing preservation in patients with tinnitus and coexisting hearing loss: study protocol for a randomized controlled trial.

Peifan Li, Dongmei Tang, Yongzhen Wu, Yanbo Yin, Shan Sun

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05343026 (Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05343026 naunknown statusnot on this map

Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss: a Randomized Controlled Trial

TypeinterventionalSponsorEye & ENT Hospital of Fudan UniversityRan2022 to 2023Enrolled62ConditionsTinnitus, Subjective, Hearing Loss, High-FrequencyArmsHearing aids
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Peifan Li *ENT Institute and Otorhinolaryngology, Department of Affiliated Eye and ENT Hospital, Key Laboratory of Hearing Medicine of NHFPC, State Key Laboratory of Medical Neurobiology, Fudan University, Shanghai, 200031, China.
Dongmei Tang *ENT Institute and Otorhinolaryngology, Department of Affiliated Eye and ENT Hospital, Key Laboratory of Hearing Medicine of NHFPC, State Key Laboratory of Medical Neurobiology, Fudan University, Shanghai, 200031, China.
Yongzhen WuENT Institute and Otorhinolaryngology, Department of Affiliated Eye and ENT Hospital, Key Laboratory of Hearing Medicine of NHFPC, State Key Laboratory of Medical Neurobiology, Fudan University, Shanghai, 200031, China.
Yanbo YinENT Institute and Otorhinolaryngology, Department of Affiliated Eye and ENT Hospital, Key Laboratory of Hearing Medicine of NHFPC, State Key Laboratory of Medical Neurobiology, Fudan University, Shanghai, 200031, China. zombayin@126.com.
Shan SunENT Institute and Otorhinolaryngology, Department of Affiliated Eye and ENT Hospital, Key Laboratory of Hearing Medicine of NHFPC, State Key Laboratory of Medical Neurobiology, Fudan University, Shanghai, 200031, China. Shansun@fudan.edu.cn.ORCID http://orcid.org/0000-0003-2142-4307
Eye & ENT Hospital of Fudan University · CN

Funding

Shanghai Municipal Health Commission 2020YJZX0110Shanghai Municipal Health Commission 2022XD059
6 · The paper itself

Abstract

backgroundChronic subjective tinnitus poses significant challenges in clinical practice, and it is usually associated with hearing impairment, particularly with high-frequency sensorineural hearing loss (SNHL). Patients suffering from tinnitus with SNHL experience one of the most severe sensory disabilities, and this has devastating effects on their quality of life. Nowadays, mild to moderate SNHL can be managed with a properly fitted hearing aid (HA) that provides sound amplification, and several studies suggest that HAs may also benefit those with tinnitus. However, inadequate attention has been paid by medical personnel to the impact of HA use in residual hearing protection for patients with tinnitus and coexisting SNHL, and existing evidence is still at a preliminary stage. This study aims to identify and evaluate the efficacy of the use of HAs in both sound perception and residual hearing preservation among patients with tinnitus and coexisting SNHL. METHODS AND

designThe present study is a prospective, single-center, outcome assessor and data analyst-blinded, randomized, controlled trial. Eligible participants will be recruited and randomly allocated into the HA intervention group and the waiting list control group at a ratio of 1:1. The primary outcome is to evaluate the severity of tinnitus using the Tinnitus Handicap Inventory as a continuous variable at 6 months from randomization. Secondary outcome measures include changes in hearing status and mental states. The trial will last 6 months, with follow-up visits at 3 months and 6 months. DISCUSSION: This will be the first randomized, controlled trial to identify and evaluate HAs' efficacy on residual hearing preservation among tinnitus patients with coexisting high-frequency SNHL in China. We are aiming for novelty and generalizability, and strengths of this study are that it will examine the effectiveness of HA in patients with tinnitus and hearing impairment and will further explore the residual hearing protection provided by HA treatment in the tinnitus group.

trial registrationClinicalTrials.gov NCT05343026. Registered on April 25, 2022.

Indexed as

DeafnessHearing AidsHearing LossHearing Loss, SensorineuralTinnitusHearingHumansPerceptionProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeHearing aidsRandomized controlled trialSensorineural hearing lossSubjective tinnitus

Identifiers

PMID36575531
PMCPMC9793655
OpenAlexW4312201111

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.