TinnitusNCT05696158
Mahana Tinnitus Pilot
A study testing MHNA-003 in people with Tinnitus, run by Mahana Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- MHNA-003
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2022to 2 Aug 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mahana Therapeutics
San Francisco, California, 94105
About this study
Official title: A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- MHNA-003
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHNA-003Device
Also called Mahana™ Tinnitus
MHNA-003 is a self-guided digital program for people living with tinnitus
| Study group | Role | What they receive |
|---|---|---|
| MHNA-003 | Experimental | MHNA-003 is a self-guided digital program for people living with tinnitus Receives: Device: MHNA-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start19 Dec 2022
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
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 TinnitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahana Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696158
- Sponsor's protocol ID
- MHNA-003-001
- Status last verified
- Nov 2023
- First submitted
- 13 Jan 2023
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
- ClinicalTrials.gov ID
- NCT05696158
- Acronym / sponsor ID
- MHNA-003-001
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mahana TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MHNA-003 | Experimental | Device: MHNA-003MHNA-003 is a self-guided digital program for people living with tinnitus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| MHNA-003Also: Mahana™ TinnitusMHNA-003 is a self-guided digital program for people living with tinnitus | Device | MHNA-003 |
Primary outcome
Mean Change in TFI Score From Baseline to Week 6
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Recruiting
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Tinnitus, Tinnitus, Bilateral
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Active, not recruitingPhase 2
TNF-α Treatment of Blast-Induced Tinnitus
Tinnitus, Noise Induced
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHNA-003 in people with Tinnitus, run by Mahana Therapeutics 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 7 inclusion and 3 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 29 Apr 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2024). 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?
Mean Change in TFI Score From Baseline to Week 6 (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 29 Apr 2024.