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Cognitive Speed as an Objective Measure of Tinnitus (COMeT)

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ClinicalTrials.gov Identifier: NCT01395368
Recruitment Status : Completed
First Posted : July 15, 2011
Results First Posted : August 23, 2012
Last Update Posted : August 23, 2012
Sponsor:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Tinnitus
Enrollment 108
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Tinnitus
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 108
Completed 92
Not Completed 16
Reason Not Completed
Physician Decision             14
Withdrawal by Subject             2
Arm/Group Title Tinnitus
Hide Arm/Group Description 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 Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
0
   0.0%
Between 18 and 65 years
83
  90.2%
>=65 years
9
   9.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
53  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
29
  31.5%
Male
63
  68.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 92 participants
92
1.Primary Outcome
Title Brain Speed Test
Hide Description 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.
Time Frame Participants completed brain speed test on the same day as enrollment. No follow-up required.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tinnitus
Hide Arm/Group Description:
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 Number of Participants Analyzed 92
Mean (95% Confidence Interval)
Unit of Measure: z-score
-0.09
(-0.23 to 0.05)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tinnitus
Hide Arm/Group Description 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.
All-Cause Mortality
Tinnitus
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tinnitus
Affected / at Risk (%)
Total   0/92 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Tinnitus
Affected / at Risk (%)
Total   0/92 (0.00%) 
Tinnitus subjects with moderate or greater depression were excluded from the study. This study may not be reflective of the population of bothersome tinnitus patients due to this exclusion
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jay F. Piccirillo, Professor
Organization: Washington University in St. Louis
Phone: 314 362-8641
Responsible Party: Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01395368     History of Changes
Other Study ID Numbers: 201103191
First Submitted: July 13, 2011
First Posted: July 15, 2011
Results First Submitted: April 13, 2012
Results First Posted: August 23, 2012
Last Update Posted: August 23, 2012