Treating Hearing Loss to Improve Mood and Cognition in Older Adults

NCT03321006 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 2 other identifiers: 7540R21AG059130
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Depression

Keywords

Aging; Late Life Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Score for Depression (HRSD)

  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.

  12 weeks

Secondary Outcomes (2)

• Clinical Global Impression Severity and Improvement (CGI)

  12 weeks

• Social Adjustment Scale Self-Report (SAS-SR) Score

  12 weeks

Study Arms (2)

Antidepressant (AD) + full amplification hearing aids

ACTIVE COMPARATOR

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

Device: Phonak Audeo B-R 90 hearing aid device (Active); Drug: Duloxetine or escitalopram

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

SHAM COMPARATOR

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

Drug: Duloxetine or escitalopram; Device: Audeo B-R 90 hearing aid device (Sham)

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

Antidepressant (AD) + full amplification hearing aids

Duloxetine or escitalopram 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.

Also known as: Cymbalta or Lexapro

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

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

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

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years
• diagnosed with Diagnostic and Statistical Manual (DSM) 5 MDD or Persistent Depressive Disorder
• have duration of depression ≥6 months
• have 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
• have moderate to severe symmetric, bilateral hearing loss (combined PTA of \>50dB at 2 and 3 kHz)
• demonstrate impaired speech discrimination scores (60- 100% on 25 word list testing) in one or both ears
• no prior history of hearing aid use within the past 6 months
• English speaking
• are willing to and capable of providing informed consent and complying with study procedures.

You may not qualify if:

• diagnosis of substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months
• history of psychosis, psychotic disorder, mania, or bipolar disorder
• diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease
• Mini Mental Status Examination (MMSE) ≤ 24
• current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers
• current suicidal ideation (HRSD suicide item \> 2) with risk of imminent self-harm
• any physical or intellectual disability adversely affecting ability to complete assessments
• acute, severe, or unstable medical or neurological illness
• contraindication to hearing aid placement
• significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma) responsible for hearing loss.
• having contraindication (e.g. metal) or unable to tolerate the scanning procedures

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hearing Loss; Depression

Interventions

Duloxetine Hydrochloride; Escitalopram

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Katharine Brewster
• Organization: NYP Institute

Katharine.Brewster@nyspi.columbia.edu

646 774 6380

Study Officials

• Bret Rutherford, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 25, 2017
• Study Start: May 30, 2018
• Primary Completion: May 31, 2021
• Study Completion: June 1, 2021
• Last Updated: October 4, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-09

Locations

US (1)