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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 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 25 participants.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321006
The ClinicalTrials.gov registry entry for NCT03321006 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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