NCT05696158

Mahana Tinnitus Pilot

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Mahana Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	MHNA-003	MHNA-003 is a self-guided digital program for people living with tinnitus

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-08-02
• Completion: 2023-08-02
• First posted: 2023-01-25
• Last updated: 2024-04-29
• Results posted: 2024-04-29

Locations

1 site across 1 country: United States