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OpenTrials
Completed

NCT Number: NCT05696158

Mahana Tinnitus Pilot

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahana Therapeutics

San Francisco, California, 94105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MHNA-003

Device

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

Other names: Mahana™ Tinnitus

Primary outcomes

  1. Mean Change in TFI Score From Baseline to Week 6

    Time frame: 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.

  2. Tinnitus Functional Index Responder Rate

    Time frame: 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. 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.

Sponsors and collaborators

Lead sponsor

Mahana Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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