Mahana Tinnitus Pilot

Tinnitus Clinical Trial

Official title:

A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696158
• Other study ID #: MHNA-003-001
• Status: Completed
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: August 2, 2023

Study information

• Verified date: November 2023
• Source: Mahana Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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

Locations

Country	Name	City	State
United States	Mahana Therapeutics	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Mahana Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 weeks
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.	6 weeks

External Links

•   Study Home Page