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Mahana Tinnitus Pilot

Sponsor
Mahana Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05696158
Collaborator
(none)
250
Enrollment
1
Location
1
Arm
5.4
Anticipated Duration (Months)
46.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MHNA-003
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
Actual Study Start Date :
Dec 19, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MHNA-003

6-week digital therapy program designed to reduce the severity of tinnitus symptoms

Device: MHNA-003
6-week digital therapy program designed to reduce the severity of tinnitus symptoms
Other Names:
  • Mahana™ Tinnitus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in TFI Score from Baseline to Week 6 [6 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahana Therapeutics San Francisco California United States 94105

    Sponsors and Collaborators

    • Mahana Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mahana Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05696158
    Other Study ID Numbers:
    • MHNA-003-001
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Feb 1, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Tinnitus

    Study Results

    No Results Posted as of Feb 1, 2023