Trial Outcomes & Findings for Processing Speed as an Objective Measure of Tinnitus (NCT NCT01222507)

Results Overview

This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

Initial study visit

Results posted on

2012-10-25

Participant Flow

Subjects were recruited from Washington University ENT and Audiology Clinics, as well as from Washington Univerity Volunteers for Health recruitment enhancement core.

2 subjects failed to meet inclusion/exclusion criteria after signing consent form.

Participant milestones

Participant milestones
Measure	Brain Speed Test (BST) 60 subjects who complete 60 Second Brain Game and Brain Speed Test
Overall Study STARTED	62
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Brain Speed Test (BST) 60 subjects who complete 60 Second Brain Game and Brain Speed Test
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Processing Speed as an Objective Measure of Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brain Speed Test n=62 Participants 60 subjects who complete 60 Second Brain Game and Brain Speed Test
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Sex: Female, Male Female	30 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Region of Enrollment United States	62 participants n=93 Participants

PRIMARY outcome

Timeframe: Initial study visit

Population: The number of subjects who completed the study according to protocol.

This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.

Outcome measures

Outcome measures
Measure	Brain Processing Speed n=60 Participants Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
Brain Speed Test	-0.28 units on a scale Interval -0.58 to 0.1

Adverse Events

Brain Speed Test

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

Dr. Jay Piccirillo

Washington University

Phone: 314-362-7508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place