Skip to main content
OpenTrials
Completed

NCT Number: NCT01864525

Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. One form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. Research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. This study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Voice Tremor Central Nervous System Diseases Dyskinesias Dysphonia Essential Tremor Essential Tremor of Voice Laryngeal Diseases Movement Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Tremor Vocal Tremor Voice Disorders Voice Tremor

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Syracuse University & Upstate Medical University

Syracuse, New York, 13210, United States

About this study

Background:

  • 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

Objectives:

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment
  • Participants show measurable voice tremor from recordings of the voice during screening appointment

Exclusion criteria

  • Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder
  • Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder)
  • Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer
  • Participants have a diagnosis of diabetes mellitus
  • Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study
  • Participants have a dependence on alcohol or allergy to alcohol
  • Participants are pregnant or lactating
  • Participants have an allergy to soy
  • Participants have Irritable Bowel Syndrome

Treatment and study plan

Octanoic acid

Drug

Other names: Caprylic acid

Inactive capsule

Drug

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 29, 2013
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.