Status:
COMPLETED
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Hearing Loss
Depression
Eligibility:
All Genders
60-99 years
Phase:
PHASE4
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 worldwi...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03321006
Start Date
May 30 2018
End Date
June 1 2021
Last Update
October 4 2021
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032