Trial Outcomes & Findings for Treating Hearing Loss to Improve Mood and Cognition in Older Adults (NCT NCT03321006)
NCT ID: NCT03321006
Last Updated: 2021-10-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-10-04
Participant Flow
Participant milestones
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Baseline characteristics by cohort
| Measure |
Antidepressant (AD) + Full Amplification Hearing Aids
n=11 Participants
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
n=14 Participants
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
72.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
75 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
74.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/ AA
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Hamilton Rating Scale for Depression
|
19.9 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
19.4 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Social Adjustment Scale- Self Report
|
2.5 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
n=12 Participants
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
n=11 Participants
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Hamilton Rating Score for Depression (HRSD)
|
12.04 score on a scale
Standard Error 1.72
|
13.86 score on a scale
Standard Error 1.67
|
SECONDARY outcome
Timeframe: 12 weeksClinical 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)
Outcome measures
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
n=11 Participants
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
n=11 Participants
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Clinical Global Impression Severity and Improvement (CGI)
|
3.17 score on a scale
Standard Error 0.33
|
3.20 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
n=11 Participants
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
n=11 Participants
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Social Adjustment Scale Self-Report (SAS-SR) Score
|
1.96 score on a scale
Standard Error 0.12
|
2.10 score on a scale
Standard Error 0.13
|
Adverse Events
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Antidepressant (AD) + Full Amplification Hearing Aids
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids
n=14 participants at risk
Participant will be randomized to sham comparator and will receive escitalopram or duloxetine + sham hearing aid for 12 weeks.
Duloxetine or escitalopram: 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): 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
|
Antidepressant (AD) + Full Amplification Hearing Aids
n=11 participants at risk
Participant will be randomized to active comparator and will receive escitalopram or duloxetine + active hearing aid for 12 weeks.
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
Duloxetine or escitalopram: 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.
|
|---|---|---|
|
Cardiac disorders
Serious Adverse Event
|
0.00%
0/14 • Adverse Events, Serious Adverse Events, and All-Cause Mortality were assesed over a period of 12 weeks.
Our definition of an an adverse event and/or serious adverse event and/or all-cause mortality did not differ from the definition of adverse event and/or serious adverse event or all-cause mortality from the clinicaltrials.gov definitions. Adverse Events, Serious Adverse Events and All-Cause Mortality was assesed over a period of 12 weeks.
|
9.1%
1/11 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality were assesed over a period of 12 weeks.
Our definition of an an adverse event and/or serious adverse event and/or all-cause mortality did not differ from the definition of adverse event and/or serious adverse event or all-cause mortality from the clinicaltrials.gov definitions. Adverse Events, Serious Adverse Events and All-Cause Mortality was assesed over a period of 12 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
All Cause Mortality
|
7.1%
1/14 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality were assesed over a period of 12 weeks.
Our definition of an an adverse event and/or serious adverse event and/or all-cause mortality did not differ from the definition of adverse event and/or serious adverse event or all-cause mortality from the clinicaltrials.gov definitions. Adverse Events, Serious Adverse Events and All-Cause Mortality was assesed over a period of 12 weeks.
|
0.00%
0/11 • Adverse Events, Serious Adverse Events, and All-Cause Mortality were assesed over a period of 12 weeks.
Our definition of an an adverse event and/or serious adverse event and/or all-cause mortality did not differ from the definition of adverse event and/or serious adverse event or all-cause mortality from the clinicaltrials.gov definitions. Adverse Events, Serious Adverse Events and All-Cause Mortality was assesed over a period of 12 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place