Nausea Clinical Trial
Official title:
Efficacy of a Non-invasive Vestibular System Masking for the Abortive Treatment of Vertigo for Patients With Acute Unilateral Vestibulopathy (AUV)
NCT number | NCT04226976 |
Other study ID # | OLith10501 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 30, 2024 |
Verified date | March 2022 |
Source | Otolith Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vestibular disorders are among the most common causes of disability in society and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Acute unilateral vestibulopathy (AUV) is easy to diagnose and is commonly treated with physical therapy exercises called vestibular rehabilitation. But due to the discomfort experienced during AUV, patients can't usually comply with the treatment plan prescribed by their healthcare provider. In this study, the investigators propose the use of an adjuvant device, the OtoBand, to improve balance, gait, reduce vertigo, and nausea in participants with AUV. Participants enrolled will undergo three vestibular tests batteries: one baseline, one with the OtoBand set at an effective power, and one with the placebo device set at low power. Neither participants nor investigator will know which device is effective and which is placebo. The OtoBand will be set at two different effective power levels. Which power level the participant will receive is randomized and unknown to the participant or investigator.
Status | Suspended |
Enrollment | 40 |
Est. completion date | June 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: Subject between the ages of 18-70 with an acute unilateral vestibulopathy as characterized by the following - Acute onset vertigo that lasts at least 6 hours within the previous 2 weeks. - A feeling of unsteadiness or feeling off balance for at least 48 hours after conclusion of vertigo - Confirmed unilateral vestibulopathy on head rotation test or caloric test Exclusion Criteria: 1. Resolved vestibular hypofunction by the time of visit to clinic 2. History of head injury within the last six months or currently suffering the effects of a head injury 3. Presence of severe aphasia 4. History of diagnosed, untreated neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia) 5. Documented neurodegenerative disorders 6. Prior disorders of hearing and balance including: 1. Ménière's disease 2. Multiple sclerosis 3. Vestibular neuritis (prior resolved episode) 4. Vestibular schwannoma 5. Sudden sensorineural hearing loss 7. History of Cerebrovascular disorders 8. History of ear operation other than myringotomy (tube placement) in the past 9. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis 10. Individuals who cannot provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Health System | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Otolith Labs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in vestibular function as measured by Functional Gait Assessment | Measure statistically significant change in postural stability in acute vestibular patients, by obtaining the participants' scores on the Functional Gait Assessment (FGA). An ANOVA will be performed on the FGA scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level. | Three tests over 30 minutes - During 1-day visit at the University of Miami Health System. | |
Primary | Change in vestibular function as measured by Dizziness Handicap Inventory | Measure statistically significant change in perception of dizziness by administering the Dizziness Handicap Inventory (DHI) immediately following the gait tasks of the Functional Gait Assessment. An ANOVA comparison will be performed between the set of DHI scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level. | Three times immediately following FGA testing - During 1-day visit at the University of Miami Health System. | |
Primary | Change in vestibular function as measured by I-PAS testing | Measure statistically significant change in vestibular function and reduction in vestibular symptoms, as measured from the participant's score on the I-PAS test battery. The I-PAS consists in "video Head Impulse Testing" (vHIT) and the "Oculomotor, Vestibular, and Reaction Time" testing (OVRT). An ANOVA comparison will be performed between the set of scoresI-PAS scores - without a device, - with an Otoband set at a subtherapeutic power level and - with an Otoband set at a therapeutic power level. | Three tests over one hour - During the 1-day visit at the University of Miami Health System. | |
Secondary | Differential effect of bone conduction level on vestibular improvements | The trial has two groups of participants: half of the participants are tested with the OtoBand set at a bone conduction level found to be optimally effective in healthy subjects, and half of the participants are tested with the OtoBand set at a higher bone conduction level. A statistical test will be used to determine whether acute unilateral vestibulopathy participants, as a group, experience higher or lower benefits from the higher bone conduction power level, using the measures of the three primary outcomes (FGA, DHI, I-PAS). | Summary data at end of study (1 year) |
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