search
Back to results

Treating Hearing Loss to Improve Mood and Cognition in Older Adults

Primary Purpose

Hearing Loss, Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Phonak Audeo B-R 90 hearing aid device (Active)
Duloxetine or escitalopram
Audeo B-R 90 hearing aid device (Sham)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Aging, Late Life Depression

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Antidepressant (AD) + full amplification hearing aids

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Global Impression Severity and Improvement (CGI)
Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (range 0-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment: range is from 0 (=normal, not at all ill) to 7 (=extremely ill, among the most extremely ill patients worsening)
Social Adjustment Scale Self-Report (SAS-SR) Score
The SAS-SR contains 54 questions that measure instrumental and expressive role performance over the past 2 weeks. Each question is rated on a 5-point scale. The overall adjustment score is obtained by summing the scores of all the items and dividing by the number of items answered. The SAS-R overall score ranges from 0-270, with higher questions indication more impairment.

Full Information

First Posted
October 19, 2017
Last Updated
September 3, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03321006
Brief Title
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Official Title
Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Depression
Keywords
Aging, Late Life Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antidepressant (AD) + full amplification hearing aids
Arm Type
Active Comparator
Arm Description
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
Arm Title
Antidepressant (AD) + Low amplification (sham) hearing aids
Arm Type
Sham Comparator
Arm Description
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Phonak Audeo B-R 90 hearing aid device (Active)
Intervention Description
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
Drug
Intervention Name(s)
Duloxetine or escitalopram
Other Intervention Name(s)
Cymbalta or Lexapro
Intervention Description
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
Device
Intervention Name(s)
Audeo B-R 90 hearing aid device (Sham)
Intervention Description
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
Primary Outcome Measure Information:
Title
Hamilton Rating Score for Depression (HRSD)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression Severity and Improvement (CGI)
Description
Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (range 0-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment: range is from 0 (=normal, not at all ill) to 7 (=extremely ill, among the most extremely ill patients worsening)
Time Frame
12 weeks
Title
Social Adjustment Scale Self-Report (SAS-SR) Score
Description
The SAS-SR contains 54 questions that measure instrumental and expressive role performance over the past 2 weeks. Each question is rated on a 5-point scale. The overall adjustment score is obtained by summing the scores of all the items and dividing by the number of items answered. The SAS-R overall score ranges from 0-270, with higher questions indication more impairment.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Rutherford, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treating Hearing Loss to Improve Mood and Cognition in Older Adults

We'll reach out to this number within 24 hrs