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NCT03321006 · ClinicalTrials.gov registry record · Phase 4

Treating Hearing Loss to Improve Mood and Cognition in Older Adults

A Phase 4 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
25
Enrollment target

NCT03321006: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.

NCT03321006 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03321006, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
25 participants
Enrollment target

Study Summary

Age-related hearing loss (ARHL) is the third most common health condition affecting older adults after heart disease and arthritis and is the fifth leading cause of years lived with disability worldwide. Many hearing-impaired older adults avoid or withdraw from social contexts in which background noise will make it difficult to communicate, resulting in social isolation and reduced communication with family and friends.Social isolation and loneliness have been linked to numerous adverse physical and mental health outcomes, including dementia, depression, and mortality, and they may also lead to declining physical activity and the development of the syndrome of frailty. In this project it is hypothesized that untreated ARHL represents a distinct route to developing Late-life Depression (LLD) and that individuals with comorbid ARHL/LLD are unlikely to respond to treatments (i.e., antidepressant medication) that do not treat the underlying hearing problem. Initial studies suggest remediation of hearing loss using hearing aids or cochlear implantation may decrease depressive symptoms acutely and over the course of 6 to 12 months follow-up. However, the clinical significance of these findings is obscured by lack of rigorous control groups, failure to objectively document hearing aid compliance, and enrollment of study populations lacking syndromal depression or even a threshold symptom score.

Primary Outcome

The patient is rated by a clinician among 24 dimensions (24-item HRSD) with a score on a 3 or 5 point scale. Maximum score is a 74. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression.

Interventions

  • DEVICE Phonak Audeo B-R 90 hearing aid device (Active)
  • DRUG Duloxetine or escitalopram
  • DEVICE Audeo B-R 90 hearing aid device (Sham)

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2018-05-30
Est. Completion 2021-06-01
Phase Phase 4

What the finished NCT03321006 record still lists

NCT03321006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which Phonak Audeo B-R 90 hearing aid device (Active) is the first listed.

NCT03321006 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03321006 about?

NCT03321006 is a clinical study titled "Treating Hearing Loss to Improve Mood and Cognition in Older Adults". Age-related hearing loss (ARHL) is the third most common health condition affecting older adults after heart disease and arthritis and is the fifth leading cause of years lived with disability worldwide. Many hearing-impaired older adults avoid or withdraw from social contexts in which background no...

What is the current status of trial NCT03321006?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-05-30. Estimated completion is 2021-06-01.

What interventions are being tested in trial NCT03321006?

The interventions under investigation include: Phonak Audeo B-R 90 hearing aid device (Active) (DEVICE), Duloxetine or escitalopram (DRUG), Audeo B-R 90 hearing aid device (Sham) (DEVICE).

Who is sponsoring clinical trial NCT03321006?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03321006's enrollment target sits among peer trials

25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03321006, the US trial registry maintained by the National Library of Medicine. NCT03321006 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.