Trial Outcomes & Findings for Mahana Tinnitus Pilot (NCT NCT05696158)

NCT ID: NCT05696158

Last Updated: 2024-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-04-29

Participant Flow

Participant milestones

Measure	MHNA-003 MHNA-003 is a self-guided digital program for people living with tinnitus
Overall Study STARTED	97
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mahana Tinnitus Pilot

Baseline characteristics by cohort

Measure	MHNA-003 n=97 Participants MHNA-003 is a self-guided digital program for people living with tinnitus
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants
Age, Continuous	56.84 years STANDARD_DEVIATION 12.10 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Intent to treat population

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.

Outcome measures

Measure	MHNA-003 n=97 Participants MHNA-003 is a self-guided digital program for people living with tinnitus
Mean Change in TFI Score From Baseline to Week 6	-20.50 score on a scale Standard Error 1.86

PRIMARY outcome

Timeframe: 6 weeks

Population: Intent to treat

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.

Outcome measures

Measure	MHNA-003 n=97 Participants MHNA-003 is a self-guided digital program for people living with tinnitus
Tinnitus Functional Index Responder Rate	61.3 percentage of responders Interval 45.6 to 77.0

Adverse Events

MHNA-003

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn Jenkins

Mahana Therapeutics

Phone: 17742666693

Email: kathryn@mahanatherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60