Mahana Tinnitus Pilot

NCT ID: NCT05696158

Last Updated: 2024-04-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2023-08-02

Brief Summary

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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

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MHNA-003

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

Group Type EXPERIMENTAL

MHNA-003

Intervention Type DEVICE

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

Interventions

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MHNA-003

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

Intervention Type DEVICE

Other Intervention Names

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Mahana™ Tinnitus

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahana Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mahana Therapeutics

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MHNA-003-001

Identifier Type: -

Identifier Source: org_study_id

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