CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Duloxetine or escitalopram +2 moredrug
Likely dose
Duloxetine or escitalopram 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03321006
NCT03321006Phase 4Completed

Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline

New York State Psychiatric Institute·interventional·Posted Oct 25, 2017·Updated Oct 4, 2021

In Brief

A Phase 4 clinical trial evaluating Phonak Audeo B-R 90 hearing aid device (Active), Duloxetine or escitalopram, and 1 other intervention for Hearing Loss and Depression. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 25, 2017
Enrollment StartMay 30, 2018
Primary CompletionMay 31, 2021
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.7 years ago

Interventions

Phonak Audeo B-R 90 hearing aid device (Active)device

Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice

Duloxetine or escitalopramdrug

We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.

Audeo B-R 90 hearing aid device (Sham)device

Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies