Vestibular Function Using Mitochondrial Antioxidant Therapy

Study Overview
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Brief Summary
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To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

Detailed Description
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The subjects will be divided into two groups, half will be given daily supplementation with ALA and CoQ-10. The second group will only receive standard of care treatment, with no study drug intervention.

Official Title
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A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year

Conditions
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Vestibular Function Disorder

Intervention / Treatment
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* Drug: Alpha Lipoic Acid 300mg
* Drug: Coenzyme Q10 200mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community dwelling non-gender specific aged 65-90 years of age For female subjects, confirm that they are post-menopausal Diagnosed with vestibular dysfunction Able to provide informed consent Prepared to adhere to study drug regimen and attend all study visits Exclusion Criteria: Unable to provide informed consent Allergy/sensitivity to the study drugs or any of their ingredients Unable to adhere to study drug regimen or to attend study visits. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven) Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs. Participants who are undergoing treatment with theophylline.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arm non-blinded controlled clinical trial. Subjects will be randomized 1: 1 either into the investigational antioxidant arm or the standard of care, no study drug arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Supplements Group<br>Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily. | Drug: Alpha Lipoic Acid 300mg<br>* A naturally occuring mitochondrial antioxidant<br>* Other names: ALA;Drug: Coenzyme Q10 200mg<br>* A naturally occuring mitochondrial antioxidant<br>* Other names: CoQ10;|
| No Intervention: Standard of Care Group<br>Standard of care treatment for vestibular function. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slow Harmonic Acceleration | Change in vestibular function using the slow harmonic acceleration rotating chair test to measure change, phase and time constant. The sinusoidal harmonic acceleration (SHA) test is a diagnostic procedure used to evaluate the vestibular system, which is responsible for maintaining balance. In the sinusoidal harmonic acceleration test, a person sits in a rotational chair that moves smoothly in controlled, rhythmic oscillations. These movements stimulate the vestibular system and induce eye movements that reflect dynamic vestibular function. Abnormal findings on the SHA test may suggest unilateral or bilateral vestibular dysfunction and provide insights into the status of central compensation for vestibular issues. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Velocity Test | Step velocity test involves sudden chair rotations and abrupt stops in both directions, which generate compensatory eye movements predominantly in response to the stimulated side. Abnormal findings during this test can suggest problems with the vestibular system, providing additional information about the affected side. | Baseline to 12 months | 
| Number of falls | A count of number of falls experienced | Baseline to 12 months | 
| Tolerance of supplements | Number of adverse events experienced | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha lipoic acid, CoQ10