Tinnitus
Conditions
Brief summary
The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.
Detailed description
Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.
Interventions
DEVICEMHNA-003
MHNA-003 is a self-guided digital program for people living with tinnitus
Sponsors
Mahana Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant scores ≥ 25 on the Tinnitus Functional Index. * Participant has experienced symptoms of tinnitus for at least 3 months. * Participant is at least 18 years of age at the time of consent. * Participant resides in the United States. * Participant is able to speak, read, and understand English. * Participant has access to an iOS or Android smartphone with the ability to complete study tasks. * Participant is able to commit the time required to complete therapy modules and study assessments.
Exclusion criteria
* Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI). * Participant has been hospitalized for psychiatric reasons within 12 months of screening. * Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in TFI Score From Baseline to Week 6 | 6 weeks | The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. An improvement of 13 or more points is considered a clinically meaningful change. |
| Tinnitus Functional Index Responder Rate | 6 weeks | The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. A responder is defined as a participant who experienced an improvement of 13 or more points from baseline to Week 6. The responder rate is the percentage of participants considered responders at Week 6. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MHNA-003 MHNA-003 is a self-guided digital program for people living with tinnitus | 97 |
| Total | 97 |
Baseline characteristics
| Characteristic | MHNA-003 |
|---|---|
| Age, Continuous | 56.84 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 85 Participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 97 |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
Primary
Mean Change in TFI Score From Baseline to Week 6
The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. An improvement of 13 or more points is considered a clinically meaningful change.
Time frame: 6 weeks
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MHNA-003 | Mean Change in TFI Score From Baseline to Week 6 | -20.50 score on a scale | Standard Error 1.86 |
Primary
Tinnitus Functional Index Responder Rate
The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. A responder is defined as a participant who experienced an improvement of 13 or more points from baseline to Week 6. The responder rate is the percentage of participants considered responders at Week 6.
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MHNA-003 | Tinnitus Functional Index Responder Rate | 61.3 percentage of responders |