Evidence map›Paper›PMID 36581413›Full record

ArticleBMJ open2022

Study protocol for a randomised controlled trial evaluating the benefits from bimodal solution with cochlear implant and hearing aid versus bilateral hearing aids in patients with asymmetric speech identification scores.

Yeliz Jakobsen, Lou-Ann Christensen Andersen, Jesper Hvass Schmidt

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

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04919928 (Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 55% of its field
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.

NCT04919928 naunknown statusnot on this map

Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids in Patients With Asymmetric Speech Identification Scores: a Randomised Controlled Trial

TypeinterventionalSponsorUniversity of Southern DenmarkRan2022 to 2025Enrolled60ConditionsHearing Loss, CochlearArmsCochlear Implant and Hearing aid in bimodal solution, Bilateral hearing aids
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

3 authors at 2 institutions in 1 country.

Yeliz JakobsenDepartment of Oto-Rhino-Laryngology, Odense University Hospital, Odense C, Denmark yeliz.jakobsen@rsyd.dk.ORCID 0000-0001-8960-7412
Lou-Ann Christensen AndersenDepartment of Ophthalmology, Vejle Hospital, Vejle, Denmark.
Jesper Hvass SchmidtDepartment of Oto-Rhino-Laryngology, Odense University Hospital, Odense C, Denmark.ORCID 0000-0001-7683-1407
Odense University Hospital · DKVejle Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCochlear implant (CI) and hearing aid (HA) in a bimodal solution (CI+HA) is compared with bilateral HAs (HA+HA) to test if the bimodal solution results in better speech intelligibility and self-reported quality of life. METHODS AND ANALYSIS: This randomised controlled trial is conducted in Odense University Hospital, Denmark. Sixty adult bilateral HA users referred for CI surgery are enrolled if eligible and undergo: audiometry, speech perception in noise (HINT: Hearing in Noise Test), Speech Identification Scores and video head impulse test. All participants will receive new replacement HAs. After 1 month they will be randomly assigned (1:1) to the intervention group (CI+HA) or to the delayed intervention control group (HA+HA). The intervention group (CI+HA) will receive a CI on the ear with a poorer speech recognition score and continue using the HA on the other ear. The control group (HA+HA) will receive a CI after a total of 4 months of bilateral HA use.The primary outcome measures are speech intelligibility measured objectively with HINT (sentences in noise) and DANTALE I (words) and subjectively with the Speech, Spatial and Qualities of Hearing scale questionnaire. Secondary outcomes are patient reported Health-Related Quality of Life scores assessed with the Nijmegen Cochlear Implant Questionnaire, the Tinnitus Handicap Inventory and Dizziness Handicap Inventory. Third outcome is listening effort assessed with pupil dilation during HINT.In conclusion, the purpose is to improve the clinical decision-making for CI candidacy and optimise bimodal solutions. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee Southern Denmark project ID S-20200074G. All participants are required to sign an informed consent form.This study will be published on completion in peer-reviewed publications and scientific conferences. TRIAL REGISTRATION NUMBER: NCT04919928.

Indexed as

Cochlear ImplantsHearing AidsSound LocalizationAdultHumansQuality of LifeRandomized Controlled Trials as TopicSpeechadult otolaryngologyaudiologyspeech pathology

Identifiers

PMID36581413
PMCPMC9806092
OpenAlexW4313331901

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.