Hearing LossPhase 4NCT03321006
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
A Phase 4 study testing Phonak Audeo B-R 90 hearing aid device (Active) and Duloxetine or escitalopram in people with Hearing Loss and Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Hearing Loss, Depression
- What is being tested?
- Phonak Audeo B-R 90 hearing aid device (Active) and Duloxetine or escitalopram
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline
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.
Read the 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.
- Conditions
- Hearing Loss, Depression
- Being tested
- Phonak Audeo B-R 90 hearing aid device (Active), Duloxetine or escitalopram, Audeo B-R 90 hearing aid device (Sham)
- Keywords
- Aging, Late Life Depression
- Medical subject headings
- Hearing Loss, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Duloxetine or escitalopramDrug
Also called Cymbalta or Lexapro
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Duloxetine or escitalopram; Device: Audeo B-R 90 hearing aid device (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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)
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start30 May 2018
- Primary completion31 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Bret Rutherford, New York State Psychiatric Institute
- Investigators
- Bret Rutherford, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321006
- Sponsor's protocol ID
- 7540
- Other IDs
- R21AG059130
- Status last verified
- Sep 2021
- First submitted
- 19 Oct 2017
- Last updated
- 4 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline
- ClinicalTrials.gov ID
- NCT03321006
- Acronym / sponsor ID
- 7540
- Conditions
- Hearing Loss, Depression
- Keywords
- Aging, Late Life Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antidepressant (AD) + full amplification hearing aids | Active comparator | Device: Phonak Audeo B-R 90 hearing aid device (Active), Drug: Duloxetine or escitalopramParticipant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks. |
| Antidepressant (AD) + Low amplification (sham) hearing aids | Sham comparator | Drug: Duloxetine or escitalopram, Device: Audeo B-R 90 hearing aid device (Sham)Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phonak Audeo B-R 90 hearing aid device (Active)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 | Device | Antidepressant (AD) + full amplification hearing aids |
| Duloxetine or escitalopramAlso: Cymbalta or LexaproWe 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. | Drug | Antidepressant (AD) + Low amplification (sham) hearing aids, Antidepressant (AD) + full amplification hearing aids |
| Audeo B-R 90 hearing aid device (Sham)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 | Device | Antidepressant (AD) + Low amplification (sham) hearing aids |
Primary outcome
Hamilton Rating Score for Depression (HRSD)
Time frame: 12 weeks
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.
2 secondary outcomes
Clinical Global Impression Severity and Improvement (CGI)
Time frame: 12 weeks
Social Adjustment Scale Self-Report (SAS-SR) Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret Rutherford, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phonak Audeo B-R 90 hearing aid device (Active) and Duloxetine or escitalopram in people with Hearing Loss and Depression, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Score for Depression (HRSD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.