Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing

Dizziness Clinical Trial

Official title:

Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03618199
• Other study ID #: Olith10101
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: Otolith Labs
• Contact: Toni White
• Phone: 410.328.2473
• Email: toni.white[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Testing for vestibular dysfunction often induces dizziness and nausea, to the point that testing cannot be completed. The investigators will use a "transcranial vibration system" that has shown promise in improving comfort during testing for vestibular disorders.

The investigators hypothesize that with this "transcranial vibration system", the dizziness and nausea associated with caloric testing will be significantly reduced, while the clinical measures derived from the test will not be statistically significantly altered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subject can speak and comprehend English.

2. Subject can stand a strap placed on their head for an hour.

Exclusion Criteria:

1. History of head injury within the last six months

2. Presence of severe aphasia

3. History of diagnosed neuropsychiatric disorders

4. Documented neurodegenerative disorders

5. Pregnancy [Female candidates will be asked if they are pregnant]

6. History of Cerebrovascular disorders

7. History of ear operation other than myringotomy and tube placement in the past

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vestibular Function Tests

Intervention

Device:
• Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the "calorics testing"stimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Otolith Labs	University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea and dizziness	Visual Analog Scales (VAS, adapted from "Visual Vertigo Analogue Scale" for dizziness and "Baxter Retching Faces (BARF)" for nausea) will be filled out by the subject ten minutes after each phase of the caloric testing, i.e. "with" and "without" the transcranial vibration system.Each phase of the caloric testing itself takes approximately 30 minutes.; These Visual Analog Scales range from 0 to 10 (None to Agonizing). They will provide independent measures of the effectiveness of the transcranial vibration system.	VAS administered ten minutes post-caloric testing; data will be analyzed upon study completion, estimated to last 6 weeks
Primary	Vestibular testing outcomes	Nystagmus associated with caloric testing (the primary clinical measure derived from caloric testing) will be compared, in the "with device" and "without device" conditions.	Vestibular clinical measures will be analyzed by a clinician upon study completion, estimated to last 6 weeks.