Mahana Tinnitus Pilot

NCT05696158 | Completed Results

• 1 other identifier: MHNA-003-001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Study Arms (1)

MHNA-003

EXPERIMENTAL

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

Device: MHNA-003

Interventions

MHNA-003 DEVICE

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

Also known as: Mahana™ Tinnitus

MHNA-003

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahana Therapeutics: lead

Study Sites (1)

Mahana Therapeutics

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kathryn Jenkins
• Organization: Mahana Therapeutics

kathryn@mahanatherapeutics.com

17742666693

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: December 19, 2022
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

Locations

US (1)