Treating Hearing Loss to Improve Mood and Cognition in Older Adults

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.

Conditions

• Hearing Loss
• Depression

Interventions

DEVICE

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

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

DRUG

Duloxetine or escitalopram

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.

DEVICE

Audeo B-R 90 hearing aid device (Sham)

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

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• New York State Psychiatric Institute

  lead OTHER

Principal Investigators

• Bret Rutherford, MD · New York State Psychiatric Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-30

Primary Completion

2021-05-31

Completion

2021-06-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations