Mahana for Tinnitus

Overseen By Kathryn Jenkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mahana Therapeutics

Disqualifiers: Suicidal thoughts, Psychiatric hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new digital program called Mahana™ Tinnitus to evaluate its effectiveness in helping people with tinnitus, a condition characterized by hearing ringing or buzzing noises not caused by an external sound. Participants will use this self-guided program alongside their usual care to assess its effectiveness and safety. It targets adults in the U.S. who have experienced tinnitus symptoms for at least three months and can use a smartphone for the study tasks. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance tinnitus management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Mahana™ Tinnitus is safe for treating tinnitus?

Studies have shown that Mahana™ Tinnitus is a safe digital program with no known side effects. This program targets individuals experiencing tinnitus, a ringing in the ears. A previous study with 97 participants found the program well-received, with no negative effects reported. Therefore, for those considering joining a trial for Mahana™ Tinnitus, the safety information appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mahana™ Tinnitus is unique because it offers a self-guided digital program specifically for people living with tinnitus, setting it apart from the typical treatments like masking devices, cognitive behavioral therapy, or medication. This approach leverages digital technology to provide accessible, personalized support, potentially empowering users to manage their symptoms more effectively on their own terms. Researchers are excited about this treatment as it could make tinnitus management more convenient and adaptable, offering an innovative alternative to traditional in-person therapies.

What evidence suggests that Mahana™ Tinnitus is effective for tinnitus?

Research shows that Mahana™ Tinnitus, a self-guided digital program, can help reduce tinnitus symptoms, which include ringing or noise in the ears. In a previous study, 69% of participants who completed more than half of the Mahana Tinnitus program noticed significant improvement in their symptoms. The program uses Cognitive Behavioral Therapy (CBT), a type of talk therapy that helps change negative thinking patterns, and is delivered through a smartphone app. These findings suggest that Mahana™ Tinnitus could effectively manage tinnitus symptoms. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant is able to commit the time required to complete therapy modules and study assessments.

You have been hearing a ringing sound in your ears for at least 3 months.

Participant resides in the United States.

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.

You are already participating in another study that could affect the results of this trial, or you plan to enroll in another study while participating in this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive access to MHNA-003 (Mahana™ Tinnitus) and use it for 6 weeks

6 weeks

Assessments at Baseline, Weeks 2, 4, and 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mahana™ Tinnitus

How Is the Trial Designed?

Group I: MHNA-003 Experimental Treatment 1 Intervention

MHNA-003 is a self-guided digital program for people living with tinnitus

Who Is Running the Clinical Trial?

Mahana Therapeutics

Lead Sponsor

Trials

2

Recruited

290+

Published Research Related to This Trial

Currently, there are no FDA-approved drugs specifically for treating tinnitus, leading to the availability of many unproven over-the-counter remedies that may cause harm without providing real benefits.

Animal models have been essential in understanding tinnitus and testing potential treatments, highlighting the need for more research to identify effective pharmacological therapies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Drugs in Animal Models of Tinnitus. Zheng, Y., McTavish, J., Smith, PF.[2021]

Citations

1.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/58/NCT05696158/Prot_SAP_000.pdf

MHNA-003-001 Protocol Synopsis V1.0

The purpose of this study is to assess the safety and clinical outcomes for MHNA-003 used together with routine care in adult patients aged 18 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05696158

Study Details | NCT05696158 | Mahana Tinnitus Pilot

MHNA-003 is a self-guided digital program for people living with tinnitus. Other Names: Mahana™ Tinnitus. What is the study measuring? Primary Outcome ...

3.

trialstat.com

trialstat.com/2024/02/evidence-from-first-mahana-tinnitus-study-accepted-for-presentation-at-upcoming-american-audiology-society-aas-annual-meeting/

Evidence From First Mahana Tinnitus Study Accepted for ...

... Digital ... 69% of those who used more than half the Mahana Tinnitus program experienced clinically significant improvement in Tinnitus as ...

4.

withpower.com

withpower.com/trial/phase-tinnitus-11-2022-08c9b

Mahana Tinnitus Pilot · Info for Participants

This trial is testing Mahana™ Tinnitus, a treatment for people who hear ringing in their ears. It involves about 250 adults who will use the treatment for ...

5.

siliconvalleyhearing.com

siliconvalleyhearing.com/blog/silicon-valley-hearing-is-now-a-mahana-tinnitus-provider

Silicon Valley Hearing is now a Mahana Tinnitus Provider

The Mahana Tinnitus App is a self-administered, self-guided program designed to deliver Cognitive Behavioral Therapy (CBT) via a smart phone app.

6.

assets-global.website-files.com

assets-global.website-files.com/61f48988f687c00c6032c430/6554a0f795e2e5396cf31dea_Mahana%20Tinnitus%20Labeling_User%20Information%20Sheet.pdf

USER INFORMATION

Mahana Tinnitus is a self-guided program that may help people live well with ... is a safe digital program with no known side effects. Page 2. 03-0006 ...