Effects of Octanoic Acid for Treatment of Essential Voice Tremor
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|ClinicalTrials.gov Identifier: NCT01864525|
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Essential Voice Tremor Vocal Tremor Voice Tremor Essential Tremor of Voice||Drug: Octanoic acid Drug: Inactive capsule||Phase 1 Phase 2|
- Essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand
- Several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication
- Researchers are interested in determining whether octanoic acid can improve tremor that affects the voice
- To determine the effects of octanoic voice using voice recordings and listener ratings of voice
- To determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Octanoic Acid for Treatment of Essential Voice Tremor|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 22, 2016|
|Actual Study Completion Date :||March 31, 2017|
Placebo Comparator: Inactive capsule
Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.
Drug: Inactive capsule
Other Name: Placebo
Experimental: Octanoic acid
Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.
Drug: Octanoic acid
Other Name: Caprylic acid
- Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor [ Time Frame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2) ]Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.
- Auditory-perceptual Tremor Severity Ratings [ Time Frame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2). ]Three experienced listeners independently rated each participant's voice from paired sample recordings comparing the baseline to post-test samples in randomized order for each condition. Sustained vowel and sentence-level recordings were rated, with decoded samples later analyzed for 1=better for post-test compared to baseline, 0= no difference between post-test and baseline. Maximum score for each participant was 3 (post-test was better for each of three raters). The range of possible scores was the sum of each of three raters' scores (0 to 3), with 0 indicating no difference between baseline and post-test voice tremor severity rating, and 3 indicating better voice (less tremor severity) at post-testing compared to pre-testing. Mean post-test values for task were compared for the octanoic acid and placebo conditions, and all raters were blind to which sample was a baseline versus a post-test recording, and which samples were associated with the [placebo or octanoic acid conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864525
|United States, New York|
|Syracuse University & Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Soren Y Lowell, PhD||Syracuse University|