Mahana Tinnitus Pilot

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

97 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mahana™ Tinnitus?

The research on sound therapy, such as the use of hearing aids with sound generators, shows that different types of noise can help relieve tinnitus symptoms. Additionally, low-powered ultrasound has been shown to improve tinnitus in some patients, suggesting that acoustic therapies can be effective in managing tinnitus. ^{1 2 3 4 5}

What safety data exists for Mahana™ Tinnitus or similar treatments?

Bojungikgitang and banhabaekchulchonmatang, herbal medicines used for tinnitus in Korea, are noted for causing very few serious adverse effects, suggesting they are generally safe for human use. ^{2 6 7 8 9}

How does the Mahana™ Tinnitus treatment differ from other tinnitus treatments?

Mahana™ Tinnitus treatment is unique because it likely involves a mindfulness-based cognitive therapy (MBCT) approach, which focuses on reducing distress associated with tinnitus through mindfulness practices. This approach is different from traditional treatments that may rely on medications or sound therapy, as it aims to create neuroanatomical changes in the brain to alleviate symptoms. ^{10 11 12 13 14}

What is the purpose of this trial?

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 several weeks. The goal is to see if it helps reduce their tinnitus symptoms.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Mahana™ Tinnitus

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hearing aids for the treatment of tinnitus. [2007]

2. England pubmed.ncbi.nlm.nih.gov

The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Designing Clinical Trials for Assessing the Effectiveness of Interventions for Tinnitus. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Low-powered ultrasound in the treatment of tinnitus: a pilot study. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

Sound Generator: Analysis of the Effectiveness of Noise in the Habituation of Tinnitus. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Drugs in Animal Models of Tinnitus. [2021]

7. England pubmed.ncbi.nlm.nih.gov

An update: emerging drugs for tinnitus. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Radix Astragali injection enhances recovery from acute acoustic trauma. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial--study protocol. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Assessing mindfulness-based cognitive therapy intervention for tinnitus using behavioural measures and structural MRI: a pilot study. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

[Interdisciplinary management of chronic tinnitus (II)]. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Heidelberg Neuro-Music Therapy Enhances Task-Negative Activity in Tinnitus Patients. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Clinical trial on tonal tinnitus with tailor-made notched music training. [2018]

14. Germany pubmed.ncbi.nlm.nih.gov

[Music therapy in chronic tonal tinnitus. Heidelberg model of evidence-based music therapy]. [2021]