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NCT03402932

Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

Completed NA Results posted Last updated 3 April 2019
What this trial tests

NA trial testing Auditory amplified in Hearing Loss, Sensorineural in 37 participants. Completed in 10 July 2018.

Timeline
1 April 2018
Primary endpoint
10 July 2018
10 July 2018

Quick facts

Lead sponsorNorthwestern University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposescreening
Enrollment37
Start date1 April 2018
Primary completion10 July 2018
Estimated completion10 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwestern University

Who can join

Adults 60 to 85, any sex, with Hearing Loss, Sensorineural or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cognitive Screening Results (Montreal Cognitive Assessment) Primary · 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.

Condition 1
GroupValue95% CI
Group1: Auditory Unamplified -Visual (Younger Adults)28.69± 1.2
Group2: Amplified-Visual (Older Adults w/ Hearing Loss)22.37± 2.82
Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)23.375± 2.34
Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)23± 2.82
Condition 2
GroupValue95% CI
Group1: Auditory Unamplified -Visual (Younger Adults)28.30± 1.13
Group2: Amplified-Visual (Older Adults w/ Hearing Loss)23.5± 2.91
Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)24.125± 1.26
Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)22.12± 2.8
Auditory Working Memory Performance Secondary · The outcome measure will be assessed immediately after the test.

Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.

Condition 1
GroupValue95% CI
Group1: Younger Control (Auditory Unamplified - Visual)82.88± 6.7
Group2: Auditory Amplified - Visual72.3± 7.1
Group3: Auditory Amplified - Unamplified69.1± 8.2
Group4: Auditory Unamplified - Visual57.5± 11.5
Condition 2
GroupValue95% CI
Group1: Younger Control (Auditory Unamplified - Visual)82.11± 7.6
Group2: Auditory Amplified - Visual66.9± 9.66
Group3: Auditory Amplified - Unamplified64.5± 11.4
Group4: Auditory Unamplified - Visual61.3± 14.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hearing Loss, Sensorineural

Currently open trials in the same condition.

Other Northwestern University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03402932.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing