Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04672174 |
| Other study ID # |
UniversitätsSpital Zürich |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2022 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hearing loss and cognitive impairment both appear in elderly patients. The goal was to use a
modified screening method added to already established cognitive tests to obtain a
standardized test for detection of cognitive impairment in patients with hearing loss.
The aim of this study is to collect data with neuropsychological tests using questionnaires
and to determine cognitive impairment in patients with hearing loss.
The collected data will be evaluated using SPSS 23. The corrected item-total correlation and
item difficulty of the item DemTectEar will be assessed by item analysis / Cronbachs' Alpha.
For further evaluation and comparisons two-sided t-tests with a level of significance 0.05 or
Mann-Whitney-U-tests will be performed.
Description:
Cognitive impairment and dementia are a growing health-care problem in our society. The
prevalence of dementia is still estimated to grow drastically and reach over a 100 million
world-wide by the year 2050. To address this problem there are numerous neuropsychological
screening methods, for example the mini-mental state examination (MMSE) or the DemTect.
Another age-dependent problem is the increasing hearing impairment. Furthermore, studies have
shown that hearing loss is associated with cognitive decline and may accelerate the process.
Nevertheless, there is no specific cognitive screening method for patients with a sensory
hearing loss.
This study aims to obtain a specifically modified version of the general DemTect called
DemTectEar for patients with pre-existing hearing loss. Such a screening method would lead to
earlier detection, earlier therapy and thereby to deceleration of cognitive decline.
Patient charts are screened to identify possible participants. They are contacted to
participate in the study during regular clinical follow-up consultations or are contacted by
phone or mail.
The investigators will explain to each participant the nature of the study, its purpose, the
procedures involved, the expected duration, the potential risks and benefits and any
discomfort it may entail. Each participant will be informed that the participation in the
study is voluntary and that he or she may withdraw from the study at any time and that
withdrawal of consent will not affect his or her subsequent medical assistance and treatment.
The participant will be informed that his or her medical records may be examined by
authorised individuals other than their treating physician.
All participants for the study will be provided a participant information sheet and a consent
form describing the study and providing sufficient information for participant to make an
informed decision about their participation in the study. Enough time, a few days or more if
required, will be given to the participant to decide whether to participate or not.
The formal consent of a participant, using the approved consent form, will be obtained before
the participant is submitted to any study procedure.
The consent form will be signed and dated by the investigator or his designee at the same
time as the participant sign. A copy of the signed informed consent will be given to the
study participant. The consent form will be retained as part of the study records.
Study procedures
The overall duration of the study is planned to be 12 months starting with the recruitment
period on September 2019. The study duration for each patient is planned to be approximately
60 min, in which each patient will be undergoing a series of neuropsychological tests and
questionnaires such as:
DemTectEar Mini Mental State Examination (MMSE) F-A-S Becks Depressions-Inventar (BOI-V)
Bayer-Activities of Daily Living Scale-Skala (B-ADL Skala) Trail Making Test (TMT)
Rey-Osterrieth Complex Figure Test - Copy and Recall (ROCFT) Mini-q Test
Nürnberger-Alters-Inventar Test (NAI-Labyrinth) Subtest 4 of the Leistungsprüfsystem für 50+
(LPS50+) Subtest 6 of the Leistungsprüfsystem für 50+ Verbaler Lern- und Merkfähigkeitstest
(VLMT) Geriatrische Depressionsskala (GDS)
Statistical analysis plan and sample size calculation The collected data will be evaluated
using SPSS 23. The corrected item-total correlation and item difficulty of the item
DemTectEar will be assessed by item analysis / Cronbachs' Alpha. For further evaluation and
comparisons two-sided t-tests with a level of significance 0.05 or Mann-Whitney-U-tests will
be performed. The primary endpoint consists of a cut-off score between age-appropriate
cognitive capability and cognitive impairment.
In total, 200 control subjects, 50 patients with a hearing loss and 50 patients with visual
impairment will be included for analysis. The majority of these patients is recruited in
Köln, and only 20 patients with hearing impairment are investigated in Zürich.
