Vestibular Function Disorder
Conditions
Keywords
Alpha lipoic acid, CoQ10
Brief summary
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
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.
Interventions
A naturally occuring mitochondrial antioxidant
DRUGCoenzyme Q10 200mg
A naturally occuring mitochondrial antioxidant
Sponsors
National Institute on Aging (NIA)
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Community dwelling non-gender specific aged 65-90 years of age 2. For female subjects, confirm that they are post-menopausal 3. Diagnosed with vestibular dysfunction 4. Able to provide informed consent 5. Prepared to adhere to study drug regimen and attend all study visits
Exclusion criteria
1. Unable to provide informed consent 2. Allergy/sensitivity to the study drugs or any of their ingredients 3. Unable to adhere to study drug regimen or to attend study visits. 4. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention. 5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 6. Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven) 7. Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs. 8. Participants who are undergoing treatment with theophylline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow Harmonic Acceleration | Baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step Velocity Test | Baseline to 12 months | 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. |
| Number of falls | Baseline to 12 months | A count of number of falls experienced |
| Tolerance of supplements | Baseline to 12 months | Number of adverse events experienced |
Countries
United States
Outcome results
None listed