{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T06:50:30Z","timestamp":1785394230746,"version":"3.55.0"},"reference-count":35,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T00:00:00Z","timestamp":1703635200000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["80-87700-98-22170"],"award-info":[{"award-number":["80-87700-98-22170"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,11,20]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Hearing 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>In this randomised controlled feasibility trial, 24 individuals aged 65 years or older with mild to moderate hearing loss (\u226535\u2013&lt;50\u2009dB pure tone average (0.5\u20134\u2009kHz) 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN84550071\">ISRCTN84550071<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-074176","type":"journal-article","created":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T07:41:06Z","timestamp":1703662866000},"page":"e074176","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Assessing the feasibility of a randomised controlled trial examining the effect of hearing aids on cognitive decline in elderly individuals: a study protocol"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"isrctn84550071","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9326-6702","authenticated-orcid":false,"given":"Denise","family":"Fuchten","sequence":"first","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adriana L","family":"Smit","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene M C","family":"Huenges Wajer","sequence":"additional","affiliation":[{"name":"UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"Experimental Psychology, Helmholtz Institute, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koen S","family":"Rhebergen","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5154-7178","authenticated-orcid":false,"given":"Inge","family":"Stegeman","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands"},{"name":"UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,12,27]]},"reference":[{"key":"2025121422441864000_13.12.e074176.1","unstructured":"World Health Organization . Global status report on the public health response to dementia; 2021."},{"key":"2025121422441864000_13.12.e074176.2","doi-asserted-by":"publisher","DOI":"10.1038\/nrneurol.2014.181"},{"key":"2025121422441864000_13.12.e074176.3","doi-asserted-by":"crossref","unstructured":"American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders: DSM-5, 5th ed. Washington D.C: American Psychiatric Publishing, 2013.","DOI":"10.1176\/appi.books.9780890425596"},{"key":"2025121422441864000_13.12.e074176.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31363-6"},{"key":"2025121422441864000_13.12.e074176.5","doi-asserted-by":"crossref","unstructured":"Prince M , Wimo A , Guerchet M , et al . World alzheimer report 2015: the global impact of dementia - an analysis of prevalence, incidence, cost and trends. Alzheimer\u2019s Disease International 2015. doi:10.1111\/j.0963-7214.2004.00293.x","DOI":"10.1111\/j.0963-7214.2004.00293.x"},{"key":"2025121422441864000_13.12.e074176.6","unstructured":"World Health Organization . Risk reduction of cognitive decline and dementia: WHO guidelines; 2019."},{"key":"2025121422441864000_13.12.e074176.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30367-6"},{"key":"2025121422441864000_13.12.e074176.8","doi-asserted-by":"crossref","DOI":"10.3389\/fnagi.2021.769405","article-title":"Hearing loss and cognition: what we know and where we need to go","volume":"13","author":"Powell","year":"2021","journal-title":"Front Aging Neurosci"},{"key":"2025121422441864000_13.12.e074176.9","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.anl.2018.08.010","article-title":"Age-related hearing loss and cognitive decline - the potential mechanisms linking the two","volume":"46","author":"Uchida","year":"2019","journal-title":"Auris Nasus Larynx"},{"key":"2025121422441864000_13.12.e074176.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.arr.2015.06.002"},{"key":"2025121422441864000_13.12.e074176.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuroimage.2013.12.059"},{"key":"2025121422441864000_13.12.e074176.12","doi-asserted-by":"crossref","DOI":"10.1212\/WNL.0000000000201562","article-title":"Author response: associations of social isolation and loneliness with later dementia","volume":"99","author":"Shen","year":"2022","journal-title":"Neurology"},{"key":"2025121422441864000_13.12.e074176.13","doi-asserted-by":"crossref","first-page":"876","DOI":"10.1001\/jamaoto.2018.1656","article-title":"Association of cognition and age-related hearing impairment in the English longitudinal study of ageing","volume":"144","author":"Ray","year":"2018","journal-title":"JAMA Otolaryngol Head Neck Surg"},{"key":"2025121422441864000_13.12.e074176.14","doi-asserted-by":"crossref","first-page":"622","DOI":"10.1177\/0194599820910377","article-title":"Hearing loss, loneliness, and social isolation: a systematic review","volume":"162","author":"Shukla","year":"2020","journal-title":"Otolaryngol--Head Neck Surg"},{"key":"2025121422441864000_13.12.e074176.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuron.2020.08.003"},{"key":"2025121422441864000_13.12.e074176.16","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1001\/jamaneurol.2022.4427","article-title":"Association of hearing AIDS and cochlear implants with cognitive decline and dementia","volume":"80","author":"Yeo","year":"2023","journal-title":"JAMA Neurol"},{"key":"2025121422441864000_13.12.e074176.17","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(23)00048-8"},{"key":"2025121422441864000_13.12.e074176.18","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0261207","article-title":"The effect of hearing aids on cognitive function: a systematic review","volume":"16","author":"Sanders","year":"2021","journal-title":"PLoS One"},{"key":"2025121422441864000_13.12.e074176.19","doi-asserted-by":"crossref","first-page":"1130","DOI":"10.1111\/jgs.15363","article-title":"Longitudinal relationship between hearing aid use and cognitive function in older Americans","volume":"66","author":"Maharani","year":"2018","journal-title":"J Am Geriatr Soc"},{"key":"2025121422441864000_13.12.e074176.20","doi-asserted-by":"crossref","first-page":"410","DOI":"10.1016\/j.trci.2017.06.003","article-title":"A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: results from the aging and cognitive health evaluation in elders pilot study","volume":"3","author":"Deal","year":"2017","journal-title":"Alzheimers Dement (N Y)"},{"key":"2025121422441864000_13.12.e074176.21","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1002\/gps.5311","article-title":"A pilot randomized controlled trial of hearing aids to improve mood and cognition in older adults","volume":"35","author":"Brewster","year":"2020","journal-title":"Int J Geriatr Psychiatry"},{"key":"2025121422441864000_13.12.e074176.22","doi-asserted-by":"crossref","first-page":"786","DOI":"10.1016\/S0140-6736(23)01406-X","article-title":"Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial","volume":"402","author":"Lin","year":"2023","journal-title":"Lancet"},{"key":"2025121422441864000_13.12.e074176.23","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2011.1408"},{"key":"2025121422441864000_13.12.e074176.24","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"2025121422441864000_13.12.e074176.25","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1002\/pst.185","article-title":"Sample size of 12 per group rule of thumb for a pilot study","volume":"4","author":"Julious","year":"2005","journal-title":"Pharmaceutical Statistics"},{"key":"2025121422441864000_13.12.e074176.26","doi-asserted-by":"publisher","DOI":"10.1097\/WAD.0b013e3181b03277"},{"key":"2025121422441864000_13.12.e074176.27","doi-asserted-by":"publisher","DOI":"10.1080\/13803390591004428"},{"key":"2025121422441864000_13.12.e074176.28","unstructured":"Kessels RPC , Bucks RS , Willisom JR , et al . Location Learning Test - Herziene Uitgave. Amsterdam: Hogrefe Uitgevers, 2012."},{"key":"2025121422441864000_13.12.e074176.29","doi-asserted-by":"publisher","DOI":"10.1207\/S15324826AN0704_8"},{"key":"2025121422441864000_13.12.e074176.30","doi-asserted-by":"publisher","DOI":"10.1177\/1073191108315611"},{"key":"2025121422441864000_13.12.e074176.31","doi-asserted-by":"crossref","unstructured":"Delis DC , Kaplan E , Kramer JH . Delis-Kaplan executive function system; 2001.","DOI":"10.1037\/t15082-000"},{"key":"2025121422441864000_13.12.e074176.32","unstructured":"Reitan RM . Trail Making Test: Manual for Administration and Scoring. Tucson, AZ: Reitan Neuropsychology Laboratory, 1992."},{"key":"2025121422441864000_13.12.e074176.33","doi-asserted-by":"publisher","DOI":"10.1007\/BF03078128"},{"key":"2025121422441864000_13.12.e074176.34","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.1983.tb09716.x"},{"key":"2025121422441864000_13.12.e074176.35","unstructured":"de Jong-Gierveld J , van Tilburg TG . Manual of the Loneliness Scale. Methoden en Technieken, 1999."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-074176","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T06:44:35Z","timestamp":1765781075000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-074176"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12]]},"references-count":35,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2023,12,27]]},"published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1136\/bmjopen-2023-074176"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-074176","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12]]}}}