ISRCTN47591507
暂停
未知
Treating Auditory impairment and CogniTion: a randomised, parallel, pilot trial in older adults with mild cognitive impairment and hearing loss of an intervention to provide and support hearing aid use vs a health education intervention for dementia risk.
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Mild cognitive impairment and hearing loss
- 发起方
- niversity College London
- 入组人数
- 76
- 状态
- 暂停
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Current participant inclusion criteria as of 01/03/2021:
- •1\. Clinical diagnosis of MCI following internationally recognised clinical criteria (ICD 10\), as diagnosed (or confirmed) by an NHS memory Service and not superseded by a diagnosis of dementia
- •2\. 55 years of age or older (as MCI under 55 is rarely linked to neurodegeneration and future dementia)
- •3\. Living in the community (not in hospital or residential care)
- •4\. Mental capacity to provide informed consent to trial procedures
- •5\. Audiometric hearing impairment. Participants must have adult\-onset hearing impairment with a four\-frequency pure tone average (0\.5, 1, 2, 4 kHz) in the better\-hearing ear of \=25 decibels Hearing Level (dB HL) and \<70 dB HL or a pure tone audiometric threshold at 4 KHz in the better ear of \=30 decibels dB HL
- •6\. Phoneme Recognition in Quiet score \=60% in better ear. A phoneme recognition in quiet score \<60% suggests hearing impairment that may be too severe to benefit from conventional amplification devices such as hearing aids
- •7\. No previous prescription of hearing aids, or, if the potential participant has been prescribed hearing aid in the past, they report no hearing aid use at all in the past month (see temporary exclusion criteria number 8a under temporary exclusion criteria), or low use because of lack of perceived efficacy. Low use is defined as less than 2 hours per day on average over the past 7 days (when at home and in usual health).
- •8\. Willingness to participate, be randomized and adhere to the protocol. Participants must be willing and able, in the opinion of the researchers, to consent to participate in the trial, to be randomized, and to adhere to the trial protocol, including willingness to wear hearing aids on a daily or near daily basis if allocated to the intervention arm, and to be followed for the duration of the trial (30 weeks)
- •TACT Remote Hearing Intervention Sub\-study (during COVID\-19\):
排除标准
- •Current participant exclusion criteria as of 01/03/2021:
- •1\. Spoken or written English is not sufficient for trial procedures, including reading of the trial materials, in the opinion of the research team
- •2\. Diagnosis of hearing loss with onset in childhood (\<18 years of age) as reported by the patient during the initial clinical interview
- •3\. Participant meets ICD\-10 criteria for current substance use disorder (abuse or dependence) or alcohol\-related brain damage
- •4\. If the audiological assessment shows that the participant meets criteria for onward medical referral (according to British Academy of Audiology criteria), and the issue has not already been investigated or addressed, we will request their permission to write to their GP with the results of our assessment and recommendation for referral. Where clinically appropriate the participant will continue in the trial, or the participant may be temporarily or permanently excluded based on the audiologist’s clinical judgement as to whether the issue identified is a contraindication for hearing aid treatment.’
- •5\. Presence of conductive hearing impairment as determined by standard audiological assessment using the difference between air audiometry and bone audiometry (air\-bone gap”) greater than 20 dB over at least 4 frequencies of 0\.5,1,2,3,4 KHz on both ears, as well as tympanometry and tuning fork test (British Academy of Audiology, 2017\). Because the impact of a conductive (versus a sensorineural) hearing loss on cognitive functioning may potentially differ and programming for hearing aids differs for conductive hearing loss, participants with permanent conductive hearing loss are excluded from the trial
- •6\. Unwillingness or inability, in the opinion of the researchers, to complete trial procedures and/or wear hearing aids on a daily or near daily basis.
- •7\. Concurrent participation in other interventional research: participants will be excluded if they are already participating in another trial
- •8\. Temporary Exclusion Criteria:
- •8\.1\. Potential participants will be excluded if hearing aids were prescribed in the past three months, irrespective of their use; however, we will contact these potential participants again after 3 months following prescription of their hearing aids and they will be eligible if they report no or low use of hearing aids. Low use is defined as less than 2 hours per day on average over the past 7 days (when at home and in usual health)
结局指标
主要结局
未指定
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