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Behavioural Intervention
1. Quality of Life (QoL) Arm for Vertigo
N/A
Waitlist Available
Led By Didier Depireux, PhD
Research Sponsored by Otolith Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post vertigo episode during the treatment phase
Awards & highlights
Study Summary
This trial studies 2 devices to provide temporary relief to adults w/ chronic vertigo, to see which works better & what degree of relief it offers. Participants are compensated & monitored through tele-health visits & daily diaries.
Eligible Conditions
- Vertigo
- Meniere's Disease
- Benign Paroxysmal Positional Vertigo
- Labyrinthitis
- Vestibular Disorder
- Vestibular Migraine
- Ménière's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes post vertigo episode during the treatment phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post vertigo episode during the treatment phase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Moderate or Worse Change in Vertigo Severity
Quality of Life Change in Scores
Secondary outcome measures
Device Effectiveness
Other outcome measures
Effectiveness of Rating Scales
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 1. Quality of Life (QoL) ArmExperimental Treatment1 Intervention
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.
Group II: 1. Moderate or Worse (MoW) ArmExperimental Treatment1 Intervention
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.
Group III: 2. Moderate or Worse (MoW) ArmPlacebo Group1 Intervention
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.
Group IV: 2. Quality of Life (QoL) ArmPlacebo Group1 Intervention
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Otoband Experimental
2023
N/A
~110
Find a Location
Who is running the clinical trial?
Otolith LabsLead Sponsor
9 Previous Clinical Trials
429 Total Patients Enrolled
6 Trials studying Vertigo
349 Patients Enrolled for Vertigo
MCRAIndustry Sponsor
29 Previous Clinical Trials
9,047 Total Patients Enrolled
1 Trials studying Vertigo
200 Patients Enrolled for Vertigo
Didier Depireux, PhDPrincipal InvestigatorOtolith Labs
5 Previous Clinical Trials
321 Total Patients Enrolled
3 Trials studying Vertigo
241 Patients Enrolled for Vertigo
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called cerebellar degeneration, which causes the neurons in the back of your brain to get worse over time.You are currently taking certain medications, like clonazepam, lorazepam, or diazepam, for problems with your balance or dizziness.You are currently doing or planning to start a type of therapy called vestibular rehabilitation. However, if you have finished the therapy but are still experiencing vertigo, you can still join the study.You have any kind of implant in your head or neck, like a cochlear implant or a device for deep brain stimulation.You are extremely sensitive to loud sounds.You have a brain tumor located in the lower part of the skull called the posterior fossa.You have a non-cancerous tumor called vestibular schwannoma on your vestibulo-cochlear nerve.You have been diagnosed with certain types of dizziness, including positional vertigo, migraines that cause dizziness, Meniere's disease, or certain types of inner ear problems.You have a history of stroke or other brain-related disorders.You have a condition called superior canal dehiscence or otic capsule dehiscence.You have been experiencing dizziness for at least 90 days.You have experienced floaters in your eyes within the past 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: 1. Quality of Life (QoL) Arm
- Group 2: 1. Moderate or Worse (MoW) Arm
- Group 3: 2. Moderate or Worse (MoW) Arm
- Group 4: 2. Quality of Life (QoL) Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vertigo Patient Testimony for trial: Trial Name: NCT05960786 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open spots available for this clinical investigation?
"Per the information on clinicaltrials.gov, this medical trial is in need of participants at present. The listing was posted for public viewing on February 2nd 2023 and has been amended most recently on July 21st 2023."
Answered by AI
Is the current trial open to elderly participants?
"The eligibility requirements for this clinical trial involve individuals between the ages of 18 and 70. Notably, there are separate studies available to cater to those younger than 18 or over 65 years old; 7 trials for minors and 66 trails specifically targeting senior citizens."
Answered by AI
To whom is eligibility for this clinical trial accessible?
"This research team is seeking 108 people who suffer from vertigo and are between the ages of 18 and 70. In order to be admitted, these criteria must be met."
Answered by AI
What is the upper limit of participants in this research initiative?
"Affirmative. Clinicaltrials.gov confirms this clinical trial is searching for study subjects, with the original posting being made on February 2nd 2023 and most recently updated July 21st 2023. The goal of this research effort is to recruit a total of 108 patients from one location."
Answered by AI
Who else is applying?
What site did they apply to?
Otolith Labs
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
i tried 4 drugs and coclear surgery. nothing helped, i lost 70% of hearing in one side and 30% in the other.
PatientReceived 1 prior treatment
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