Hearing Loss, SensorineuralNCT03402932
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
A study testing Auditory amplified, Visual and Auditory unamplified in people with Hearing Loss, Sensorineural and Cognitive Impairment, run by Northwestern University at 1 site in United States.
Trial summary
The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Cognitive Impairment
- What is being tested?
- Auditory amplified, Visual and Auditory unamplified
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 10 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have sensorineural hearing loss
- Have normal or corrected-to-normal vision
Who cannot join
- Have conductive hearing loss;
- Have history of otologic or neurologic disorders
- Have dementia
- Non-native speakers of English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss
The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.
Read the detailed description
Aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. Data will be collected from younger individuals with normal hearing. Each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. It is anticipated that the scores will not be significantly different between the two conditions.
Aim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. The three test conditions include auditory unamplified, auditory amplified, and visual. Each older individual will be tested using two different test conditions. It is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.
- Conditions
- Hearing Loss, Sensorineural, Cognitive Impairment
- Being tested
- Auditory amplified, Visual, Auditory unamplified
- Medical subject headings
- Hearing Loss, Sensorineural, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory amplifiedOther
The cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds.
VisualOther
The cognitive test will be administered visually by using timed computer slides.
Auditory unamplifiedOther
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
| Study group | Role | What they receive |
|---|---|---|
| Auditory Amplified-Visual | Experimental | This arm is designed to test the contrast between auditory amplified and visual conditions. Receives: Other: Auditory amplified; Other: Visual |
| Auditory Amplified-Unamplified | Experimental | This arm is designed to test the contrast between auditory amplified and unamplified conditions. Receives: Other: Auditory amplified; Other: Auditory unamplified |
| Auditory Unamplified-Visual | Experimental | This arm is designed to test the contrast between auditory unamplified and visual conditions. Receives: Other: Visual; Other: Auditory unamplified |
| Younger control group | Other | This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls. Receives: Other: Visual; Other: Auditory unamplified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Screening Results (Montreal Cognitive Assessment)
The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table).
MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance.
Measured: The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.
Secondary outcomes (1)
Auditory Working Memory Performance
Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.
Measured: The outcome measure will be assessed immediately after the test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Apr 2018
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Shen, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402932
- Sponsor's protocol ID
- 2R01DC012289
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2018
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be shared in the form of presentations and publications. Study protocol is available upon request.
Publications
Jorgensen LE, Palmer CV, Pratt S, Erickson KI, Moncrieff D. The Effect of Decreased Audibility on MMSE Performance: A Measure Commonly Used for Diagnosing Dementia. J Am Acad Audiol. 2016 Apr;27(4):311-23. doi: 10.3766/jaaa.15006.
PubMed 27115241Guerreiro MJS, Van Gerven PWM. Disregarding hearing loss leads to overestimation of age-related cognitive decline. Neurobiol Aging. 2017 Aug;56:180-189. doi: 10.1016/j.neurobiolaging.2017.05.001. Epub 2017 May 10.
PubMed 28559106Lin 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.
PubMed 23337978Dupuis K, Pichora-Fuller MK, Chasteen AL, Marchuk V, Singh G, Smith SL. Effects of hearing and vision impairments on the Montreal Cognitive Assessment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2015;22(4):413-37. doi: 10.1080/13825585.2014.968084. Epub 2014 Oct 17.
PubMed 25325767
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss
- ClinicalTrials.gov ID
- NCT03402932
- Acronym / sponsor ID
- 2R01DC012289
- Conditions
- Hearing Loss, Sensorineural, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 3 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.
Detailed description
Aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. Data will be collected from younger individuals with normal hearing. Each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. It is anticipated that the scores will not be significantly different between the two conditions.
Aim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. The three test conditions include auditory unamplified, auditory amplified, and visual. Each older individual will be tested using two different test conditions. It is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Auditory Amplified-Visual | Experimental | Other: Auditory amplified, Other: VisualThis arm is designed to test the contrast between auditory amplified and visual conditions. |
| Auditory Amplified-Unamplified | Experimental | Other: Auditory amplified, Other: Auditory unamplifiedThis arm is designed to test the contrast between auditory amplified and unamplified conditions. |
| Auditory Unamplified-Visual | Experimental | Other: Visual, Other: Auditory unamplifiedThis arm is designed to test the contrast between auditory unamplified and visual conditions. |
| Younger control group | Other | Other: Visual, Other: Auditory unamplifiedThis arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have sensorineural hearing loss
- Have normal or corrected-to-normal vision
Key exclusion criteria (4 listed)
- Have conductive hearing loss;
- Have history of otologic or neurologic disorders
- Have dementia
- Non-native speakers of English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory amplifiedThe cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds. | Other | Auditory Amplified-Unamplified, Auditory Amplified-Visual |
| VisualThe cognitive test will be administered visually by using timed computer slides. | Other | Auditory Amplified-Visual, Auditory Unamplified-Visual, Younger control group |
| Auditory unamplifiedThe cognitive test will be administered by using a generic presentation level that simulates a normal conversational level. | Other | Auditory Amplified-Unamplified, Auditory Unamplified-Visual, Younger control group |
Primary outcome
Cognitive Screening Results (Montreal Cognitive Assessment)
Time frame: The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.
The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table). MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance.
1 secondary outcome
Auditory Working Memory Performance
Time frame: The outcome measure will be assessed immediately after the test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27115241Jorgensen LE, Palmer CV, Pratt S, Erickson KI, Moncrieff D. The Effect of Decreased Audibility on MMSE Performance: A Measure Commonly Used for Diagnosing Dementia. J Am Acad Audiol. 2016 Apr;27(4):311-23. doi: 10.3766/jaaa.15006.
- Background: PubMed 28559106Guerreiro MJS, Van Gerven PWM. Disregarding hearing loss leads to overestimation of age-related cognitive decline. Neurobiol Aging. 2017 Aug;56:180-189. doi: 10.1016/j.neurobiolaging.2017.05.001. Epub 2017 May 10.
- Background: PubMed 23337978Lin 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.
- Background: PubMed 25325767Dupuis K, Pichora-Fuller MK, Chasteen AL, Marchuk V, Singh G, Smith SL. Effects of hearing and vision impairments on the Montreal Cognitive Assessment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2015;22(4):413-37. doi: 10.1080/13825585.2014.968084. Epub 2014 Oct 17.
- Individual participant dataSharing planned: Undecided. The results will be shared in the form of presentations and publications. Study protocol is available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory amplified, Visual and Auditory unamplified in people with Hearing Loss, Sensorineural and Cognitive Impairment, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Screening Results (Montreal Cognitive Assessment) (time frame: The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402932, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.