N/A
Completed N=97
Mahana Tinnitus Pilot
Source: ClinicalTrials.gov NCT05696158 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Mean Change in TFI Score From Baseline to Week 6 — -20.50 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in TFI Score From Baseline to Week 6 |
-20.50 | — |
| PRIMARY Tinnitus Functional Index Responder Rate |
61.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05696158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.