Mild cognitive impairment and hearing loss Nervous System Diseases Mild cognitive disorder, hearing loss
Conditions
Interventions
Current interventions as of 01/03/2021:
Hearing intervention:
Home-based hearing aid fitting and one-to-one adherence support over 12 weeks.
Healthy Ageing Intervention:
Home-based, one-to-one ses
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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internationally recognised clinical criteria (ICD 10), as diagnosed (or confirmed) by an NHS memory Service and not superseded by a diagnosis of dementia 2. 55 years of age or older (as MCI under 55 is rarely linked to neurodegeneration and future dementia) 3.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 = 25 decibels Hearing Level (dB HL) and = 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 a
Exclusion criteria
Exclusion criteria: 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) 8.2. Participants determined to have occluding cerumen as per otoscopy. These participants may be enrolled after cerumen removal. We will advise participants with occluding cerumen to access accredited cerumen removal services, following recent NICE guidelines (https://cks.nice.org.uk/earwax, and “Hearing loss in adults: assessment and management”; NICE Guideline, June 2018 [NG98]). Participants who are identified as needing cerumen removal will be advised to consult their GP to arrange cerumen removal. They will also be offered reimbursement if they choose to have privately arranged cerumen removal by an accredited provider instead. If practicable, and at the discretion of the trial audiologist, participants may also be offered cerumen removal by the trial audiologist, who has undergone necessary training for cerumen removal procedures TACT Remote Hearing Intervention Sub-study (during COVID-19): 1. In the opinion of the research team, would be unable to complete remote procedures 2. Report any new ear pain or discharge or any aud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/03/2021: This pilot trial aims at establishing the feasibility of a full-size trial of the hearing aid intervention versus healthy ageing intervention in people with MCI. The pilot’s primary objective is therefore to establish feasibility of recruitment, randomisation, retention, and the acceptability of the trial interventions as follows: 1. Recruitment and randomisation: Proportion of eligible participants who are randomised into the trial 2. Retention: proportion of participants who are followed for the 6 months of trial duration, and endpoint measures are obtained 3. Acceptability of the Hearing Intervention: proportion of participants allocated to the Hearing Intervention completing =2 intervention sessions TACT Remote Hearing Intervention Sub-study (during COVID-19): The Primary outcome of the Remote Hearing Intervention sub-study in keeping with the overall TACT primary objective, will be the feasibility of the Remote Hearing Intervention, in terms of: 1. Recruitment: achieving n=12 participants 2. Acceptability of the Remote Hearing Intervention proportion of participants allocated to the Hearing Intervention completing =2/3 intervention sessions– expected value =80%. 3. Retention: proportion of participants completing outcome collection– expected value =80%. Previous primary outcome measure: This pilot trial aims at establishing the feasibility of a full-size trial of the hearing aid intervention versus healthy ageing intervention in people with MCI. The pilot’s primary objective is therefore to establish feasibility of recruitment, randomisation, retention, and the acceptability of the trial interventions as follows: 1. Recruitment and randomisation: Proportion of eligible participants who are randomised into the trial 2. Retention: proportion of participants who are followed for the 6 months of trial duration, and endpoint measures are obtained 3. Acceptability of the Hearing Intervention: proportion of participa | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/03/2021: 1. Proportion of participants maintaining hearing aid use, defined as a minimum of 4h a day on average since last trial assessment (when at home and in usual health) as established by data-logging at 6 months (end of trial), based on the hearing aid with the highest average use (as each participant has two hearing aids). Self-reported hearing aid use may also be employed if needed, for instance, if no data-logging is available for a participant 2. Participants rating of the interventions based on Likert scale scores. 3. Cognitive scales and the following other trial outcomes: 3.1. Delayed word recall test (DWRT): encoding and recall 3.2. Addenbrooke Cognitive Examination (ACE-III) 3.3. Trail Making Test (TMT) Part A and B 3.4. Self-reported hearing disability - Hearing Handicap Inventory for the Elderly – Screening version (HHIE-S) 3.5. Geriatric depression scale (GDS) 3.6. Quality of life questionnaires: Short Form 36 and EQ-5D 3.7. Items of the Lawton – Brody Instrumental Activities Of Daily Living Scale (I.A.D.L.): A. Telephone, F. Transport, G. Medication, H. Finances 3.8. Social function scale SF-DEM – patient rated version 3.9. UCLA Version 3 Loneliness Scale 3.10. Grip strength 3.11. Accelerometer 4. Communication Partner (when available): 4.1.The Hearing Impairment Impact–Significant Other Profile 4.2. Health-related quality of life of communication partner with SF36 and EQ-5D 4.3. Hospital anxiety and depression HADS 4.4. Carer-rated version of the SF-DEM 4.5. Brody Instrumental Activities Of Daily Living Scale 5. Number of potential participants referred to the study researchers, screening visits scheduled and completed 6. Feasibility of the schedule of assessments, which will include proportion of completed interviews and completion rates of instruments and questionnaires, as well as relevant biometric data 7. Completion rates of the interventions by recording the proportion of participants w | — |
Countries
England, United Kingdom
Contacts
Public ContactKingsley Powell
Outcome results
None listed