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NCT04049643 · ClinicalTrials.gov registry record · NA
Hearing Aid and Individuals With Cognitive Disorders
A NA study of Mild Cognitive Impairment and Presbycusis, Bilateral, sponsored by Yu-Hsiang Wu.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT04049643: Completed NA study of Mild Cognitive Impairment and Presbycusis, Bilateral, sponsored by Yu-Hsiang Wu.
NCT04049643 is a NA study of Mild Cognitive Impairment and Presbycusis, Bilateral that has completed, run by Yu-Hsiang Wu. The registered enrollment target is 17 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04049643, a NA study of Mild Cognitive Impairment and Presbycusis, Bilateral, has completed, sponsored by Yu-Hsiang Wu.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with Alzheimer's Disease and related dementias (ADRD). In this pilot study individuals with mild or moderate cognitive impairment, as well as their caregivers, will be recruited. Participants will be randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Outcome data will be collected on the how hearing loss and hearing aid impact their lives and caregiver burden 6-week post hearing aid intervention.
Primary Outcome
The IOI-HA is a questionnaire designed to assess the benefits of hearing aids from the user's perspective. The score ranges from 1 (less benefit) to 5 (more benefit).
Conditions Studied
Interventions
- DEVICE Audiologist-based fitting
- DEVICE Service-only Fitting
- DEVICE Device-only fitting
Study Locations (2)
Iowa
- University of Iowa - Iowa City
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2024-11-07 |
| Phase | NA |
What the finished NCT04049643 record still lists
NCT04049643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 3 interventions - of which Audiologist-based fitting is the first listed.
NCT04049643 reports a single indexed study location in Iowa, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04049643 about?
NCT04049643 is a clinical study titled "Hearing Aid and Individuals With Cognitive Disorders". This is a pilot study with the aim of evaluating the feasibility of the procedures of a future clinical trial that will help determine the impacts of hearing aid interventions on older patients with Alzheimer's Disease and related dementias (ADRD). In this pilot study individuals with mild or modera...
What is the current status of trial NCT04049643?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2019-12-01. Estimated completion is 2024-11-07.
What conditions does trial NCT04049643 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Presbycusis, Bilateral, Alzheimer Disease 2 Due to Apoe4 Isoform.
What interventions are being tested in trial NCT04049643?
The interventions under investigation include: Audiologist-based fitting (DEVICE), Service-only Fitting (DEVICE), Device-only fitting (DEVICE).
Who is sponsoring clinical trial NCT04049643?
This trial is sponsored by Yu-Hsiang Wu, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04049643 being conducted?
This trial has 2 study locations across Iowa, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04049643's enrollment target sits among peer trials
17 186th of 205 higher than 19 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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