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Treating Hearing Loss to Improve Mood and Cognition in Older Adults

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ClinicalTrials.gov Identifier: NCT03321006
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bret Rutherford, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Depression Device: Audio B-R 90 hearing aid device Drug: Duloxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AD + full amplification hearing aids Device: Audio B-R 90 hearing aid device
Hearing aids will be the latest Audio B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies; Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice

Drug: Duloxetine
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.
Other Name: escitalopram

Sham Comparator: AD + Low amplification (sham) hearing aids Device: Audio B-R 90 hearing aid device
Hearing aids will be the latest Audio B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies; Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice

Drug: Duloxetine
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.
Other Name: escitalopram




Primary Outcome Measures :
  1. Hamilton Rating Score for Depression (HRSD) [ Time Frame: 12 weeks ]
    The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.


Secondary Outcome Measures :
  1. Clinical Global Impression Severity and Improvement (CGI) [ Time Frame: 12 weeks ]
    Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment: 0 normal, not at all ill to 7 Among the most extremely ill patients worsening.

  2. Social Adjustment Scale Self-Report (SAS-SR) Score [ Time Frame: 12 weeks ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 18
  5. have moderate to severe symmetric, bilateral hearing loss (combined PTA of 50-80 dB at 0.5, 1, 2, 3 kHz)
  6. demonstrate impaired speech discrimination scores (50-80% on 25 word list testing)
  7. no prior history of hearing aid use
  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. history of allergy, hypersensitivity reaction, or severe intolerance to duloxetine or escitalopram
  7. current suicidal ideation (HRSD suicide item > 2) with risk of imminent self-harm
  8. any physical or intellectual disability adversely affecting ability to complete assessments
  9. acute, severe, or unstable medical or neurological illness
  10. contraindication to hearing aid placement
  11. significant retrocochlear pathology or organic brain lesion (e.g., acoustic neuroma) responsible for hearing loss.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321006


Contacts
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Contact: Veronika S Bailey, MA 646-774-8655 veronika.bailey@nyspi.columbia.edu
Contact: Xiaoyan Xu, PhD 646-774-5568 Xiaoyan.Xu@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Veronika Bailey, MA    646-774-8655    vbailey@nyspi.columbia.edu   
Principal Investigator: Bret R Rutherford, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Bret Rutherford, MD New York State Psychiatric Institute

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Responsible Party: Bret Rutherford, Associate Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03321006     History of Changes
Other Study ID Numbers: 7540
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Citalopram
Duloxetine Hydrochloride
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents