Back to resultsMahana Tinnitus Pilot
Primary Purpose
Tinnitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MHNA-003
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
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.
Sites / Locations
- Mahana Therapeutics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MHNA-003
Arm Description
6-week digital therapy program designed to reduce the severity of tinnitus symptoms
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05696158
Brief Title
Mahana Tinnitus Pilot
Official Title
A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
August 2, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahana Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MHNA-003
Arm Type
Experimental
Arm Description
6-week digital therapy program designed to reduce the severity of tinnitus symptoms
Intervention Type
Device
Intervention Name(s)
MHNA-003
Other Intervention Name(s)
Mahana™ Tinnitus
Intervention Description
6-week digital therapy program designed to reduce the severity of tinnitus symptoms
Primary Outcome Measure Information:
Title
Change in TFI Score from Baseline to Week 6
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mahana Therapeutics
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.mahana.com/tinnitus
Description
Study Home Page
Learn more about this trial
Mahana Tinnitus Pilot
We'll reach out to this number within 24 hrs