Trial Outcomes & Findings for Cognitive Speed as an Objective Measure of Tinnitus (NCT NCT01395368)
NCT ID: NCT01395368
Last Updated: 2012-08-23
Results Overview
Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.
COMPLETED
108 participants
Participants completed brain speed test on the same day as enrollment. No follow-up required.
2012-08-23
Participant Flow
Participants were recruited from Washington University's Volunteer for Health office, the audiology division and the otolaryngology faculty clinical practices at Washington University Department of Otolaryngology-Head and Neck Surgery, including the PI's population of tinnitus patients.
Participant milestones
| Measure |
Tinnitus
Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Tinnitus
Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
|
|---|---|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Cognitive Speed as an Objective Measure of Tinnitus
Baseline characteristics by cohort
| Measure |
Tinnitus
n=92 Participants
Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age Continuous
|
53 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants completed brain speed test on the same day as enrollment. No follow-up required.Population: Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.
Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.
Outcome measures
| Measure |
Tinnitus
n=92 Participants
Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
|
|---|---|
|
Brain Speed Test
|
-0.09 z-score
Interval -0.23 to 0.05
|
Adverse Events
Tinnitus
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jay F. Piccirillo, Professor
Washington University in St. Louis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place