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COMPLETED NA

Hearing Aid and Individuals With Cognitive Disorders

NCT04049643 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 17 participants
Start Date 2019-12-01
Est. Completion 2024-11-07
Phase NA

Sponsor

Yu-Hsiang Wu

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04049643

The ClinicalTrials.gov registry entry for NCT04049643 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yu-Hsiang Wu, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04049643 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Iowa, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04049643?

This trial is sponsored by Yu-Hsiang Wu, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial