Clinical trial NCT03321006: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hearing Loss
Depression
Keywords: Aging
Late Life Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-10-25
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Rating Score for Depression (HRSD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Global Impression Severity and Improvement (CGI)
timeFrame: 12 weeks
measure: Social Adjustment Scale Self-Report (SAS-SR) Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Bret Rutherford, MD
role: PRINCIPAL_INVESTIGATOR
References: