Treating Hearing Loss to Improve Mood and Cognition in Older Adults

NCT ID: NCT03321006

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2021-06-01

Brief 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.

Detailed Description

This study will conduct the first clinical trial possessing these design features 40 individuals will be recruited who are aged ≥60 years, diagnosed with a clinically significant depressive disorder, and have moderate ARHL with impaired speech discrimination. Comprehensive baseline psychiatric, audiometric, neuropsychological, and functional assessment will be performed. Participants then will be randomized to receive antidepressant medication (AD) treatment plus full amplification hearing aids or antidepressant medication plus low amplification hearing aids over a 12-week prospective trial. Data from this study could suggest a novel therapeutic strategy for LLD and thereby mitigate its public health burden, while also contributing to the increased recognition and treatment of ARHL more generally.

Conditions

Hearing Loss; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Antidepressant (AD) + full amplification hearing aids

Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 escitalopram

Intervention Type: DRUG

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.

Antidepressant (AD) + Low amplification (sham) hearing aids

Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.

Group Type: SHAM_COMPARATOR

Duloxetine or escitalopram

Intervention Type: DRUG

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)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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

Intervention Type: DEVICE

Other Intervention Names

Cymbalta or Lexapro

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 60 years

2. diagnosed with Diagnostic and Statistical Manual (DSM) 5 MDD or Persistent Depressive Disorder

3. have duration of depression ≥6 months

4. have 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16

5. have moderate to severe symmetric, bilateral hearing loss (combined PTA of >50dB at 2 and 3 kHz)

6. demonstrate impaired speech discrimination scores (60- 100% on 25 word list testing) in one or both ears

7. no prior history of hearing aid use within the past 6 months

8. English speaking

9. are willing to and capable of providing informed consent and complying with study procedures.

Exclusion Criteria

1. diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months

2. history of psychosis, psychotic disorder, mania, or bipolar disorder

3. diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease

4. Mini Mental Status Examination (MMSE) ≤ 24

5. current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers

6. current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm

7. any physical or intellectual disability adversely affecting ability to complete assessments

8. acute, severe, or unstable medical or neurological illness

9. contraindication to hearing aid placement

10. significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma) responsible for hearing loss.

11. having contraindication (e.g. metal) or unable to tolerate the scanning procedures

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Bret Rutherford

Associate Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bret Rutherford, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R21AG059130

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7540

Identifier Type: -

Identifier Source: org_study_id