Validation of Cognitive Screenings for the Hearing Impaired

NCT03648502 | Terminated DMC

• 1 other identifier: 18/0306
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

There are currently no cognitive tests that have been validated as screening tools for people with dementia and comorbid hearing loss. This is particularly important given the high prevalence of hearing impairment in older adults presenting to memory services and the risk of misdiagnosis of dementia in this population as outlined above. Cognitive tests validated in hearing impaired populations will also be important as outcome tools for interventional research aiming to find out if treating hearing loss may reduce dementia risk in the longer term.

Conditions

Dementia; Hearing Loss; Auditory Processing Disorder

Keywords

dementia; hearing loss; auditory process

Outcome Measures

Primary Outcomes (2)

• The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.

  The score will be used to calculate the appropriate cut-point score for differentiating each group of hearing impaired older adults.(total score ranging from 0-30 points with higher score indicate better cognitive function)

  approximately 1 years (expected to recruit 30 participants for each group)

• The adapted version Addenbrooke's Cognitive Examination III (ACE-III) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.

  The score will be used to calculate the appropriate cut-point score for differentiating each group of hearing impaired older adults (total score ranging from 0-100 points with higher score indicate better cognitive function)

  approximately 1 years (expected to recruit 30 participants for each group)

Secondary Outcomes (1)

• Hearing handicap score from the Modified Amsterdam Inventory for Auditory Disability and Handicap (mAIAD) (total score ranging from 0-84 with higher score indicate smaller perceived hearing difficulty)

  approximately 1 years (expected to recruit 30 participants for each group)

Other Outcomes (1)

• Final cognitive status diagnosis (base on ICD-10 coding system; dichotomous outcome; code F00-F03 (dementia) or code ICD F06.7 (Mild cognitive impairment)) provided by an NHS memory service doctors at routine clinical care follow up session at 1 year.

  1 year follow up from initial recruitment

Study Arms (3)

dementia (D-HI)

EXPERIMENTAL

hearing impaired dementia

Diagnostic Test: Cognitive tests and hearing tests

Mild cognitive impairment (MCI-HI)

OTHER

MCI with hearing loss

Diagnostic Test: Cognitive tests and hearing tests

normal (N-HI)

ACTIVE COMPARATOR

normal cognition with hearing loss

Diagnostic Test: Cognitive tests and hearing tests

Interventions

Cognitive tests and hearing tests DIAGNOSTIC_TEST

Several cognitive and hearing (peripheral and (central) auditory process) tests

Mild cognitive impairment (MCI-HI); dementia (D-HI); normal (N-HI)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age over 65 years
• Documented Hearing loss (currently wearing hearing aids and/or hearing testing with a hearing average of \>/= 30dB HL in D-HI,MCI-HI group)

You may not qualify if:

• Uncorrected visual impairment; cognitive and/or physical disability(s) which prevent the performance of the written/drawing elements of the tests, in the opinion of the researcher.
• Severe to profound hearing loss (PTA \>70dBHL)

Sponsors & Collaborators

• University College, London: lead

Study Sites (2)

Royal National Throat Nose Ear Hospital

London, WC1X 8DA, United Kingdom

Location

Camden and Islington NHS memory service

London, United Kingdom

Location

Related Publications (2)

• MacDonald AA, Joyson A, Lee R, Seymour DG, Soiza RL. The effect of hearing augmentation on cognitive assessment scales at admission to hospital. Am J Geriatr Psychiatry. 2012 Apr;20(4):355-61. doi: 10.1097/JGP.0b013e3182107e88.

  PMID: 22434018 RESULT

• Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.

  PMID: 23337978 RESULT

MeSH Terms

Conditions

Dementia; Hearing Loss; Auditory Perceptual Disorders

Interventions

Hearing Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Auditory Diseases, Central; Retrocochlear Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nattawan Utoomprurkporn, MD,Msc

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 participants arms Diagnostic tools validation

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 27, 2018
• Study Start: November 9, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)