ArticleBMJ open2023
Assessing the feasibility of a randomised controlled trial examining the effect of hearing aids on cognitive decline in elderly individuals: a study protocol.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHearing loss is one of the leading potentially modifiable risk factors for dementia. There is growing evidence suggesting that treating hearing loss with hearing aids could be a relatively low-cost intervention in reducing cognitive decline and the risk of dementia in the long term. However, given the current constraints of the limited evidence, it is premature to draw definitive conclusions about the effect of hearing aids on cognitive functioning. More long-term randomised studies examining this effect would be recommended. Prior to embarking on large-scale lengthy randomised controlled trials (RCTs), it is imperative to determine the viability of such studies. Therefore, the purpose of the current study is to assess the feasibility of a RCT that investigates the effect of hearing aids on cognitive functioning in elderly hearing impaired individuals. METHODS AND ANALYSIS: In this randomised controlled feasibility trial, 24 individuals aged 65 years or older with mild to moderate hearing loss (≥35-<50 dB pure tone average (0.5-4 kHz) unilateral or bilateral) will be included and randomised towards a hearing aid intervention or no intervention. At baseline and at 6-month follow-up, a test battery consisting of cognitive tests and questionnaires will be administered to both groups. The primary outcome of the study is the willingness of hearing impaired individuals to be randomised for hearing amplification in a study regarding cognition. The secondary outcomes are the feasibility of the test battery and the therapy compliance of hearing aid use. ETHICS AND DISSEMINATION: This research protocol was approved by the Institutional Review Board of the University Medical Centre Utrecht (NL80594.041.22, V.3, January 2023). The trial results will be made accessible to the public in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN84550071.
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