Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869020
Status:
UNKNOWN
Last Update Posted:
2022-03-29
First Post:
2021-04-23
Brief Title:
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
Sponsor:
Otolith Labs
Organization:
Otolith Labs
Study Overview
Official Title:
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to gather data on the effect of a device the OtoBand in participants who have reported symptoms of vertigo compared to the effect of using one of two sham devices The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study
Detailed Description:
In this phase of this pilot study a minimum of 20 participants will be enrolled with up to 100 participants maximum This will provide adequately powered pilot data to measure effect size for the OtoBand and sham devices and to identify different causes of vertigo for which the OtoBand has a particularly strong effect as measured by the Otolith Vertigo Assessment Tool After inclusionexclusion screening and informed consent is obtained potential participants will be assessed using the Dizziness Handicap Inventory DHI The DHI will be completed online
Potential participants with a DHI score in the appropriate range will be accepted into the study These participants will be asked to schedule an online meeting to with the study coordinator In this online enrollment meeting the study coordinator will review the Informed Consent and confirm other information supplied by the participant online inclusionexclusion and then make an affirmative decision to enroll or not enroll participants in the study
The participants will be randomly assigned to one of the two arms of the study OtoBand Sham Device A or OtoBand Sham Device B This is a blinded study in which every participant will be evaluated and each participant may select the stimulation that best suits him or her on both of the study devices
Each participant will select hisher preferred stimulation level by pressing the power level button on the study device however they will be blinded to which device they are using Study participants will be asked to use the devices whenever they are having a symptom of vertigo Each participant will be asked to record hisher level of vertigo in the online Study Diary before putting on the device after wearing the device for 5 minutes after removing the device
The study devices will record the following information regarding usage Date and time when the device is turned onoff and the power level Date and time when the power level is changed and the new power level
Participants will be allowed to use the device as long as they are getting benefit from the device at any power setting that they select Participants will be asked to complete an entry in the Study Diary even on days on which they do not experience a vertigo episode
The study coordinator will schedule six study monitoring call with each participant as close as possible to the following schedule
Call 1 Device I 4 days after enrollment Call 2 Device I 9 days after enrollment Call 3 Device I 14 days after enrollment Call 4 Device II 17 days after enrollment Call 5 Device II 22 days after enrollment Call 6 Device II 27 days after enrollment
Potential participants with a DHI score in the appropriate range will be accepted into the study These participants will be asked to schedule an online meeting to with the study coordinator In this online enrollment meeting the study coordinator will review the Informed Consent and confirm other information supplied by the participant online inclusionexclusion and then make an affirmative decision to enroll or not enroll participants in the study
The participants will be randomly assigned to one of the two arms of the study OtoBand Sham Device A or OtoBand Sham Device B This is a blinded study in which every participant will be evaluated and each participant may select the stimulation that best suits him or her on both of the study devices
Each participant will select hisher preferred stimulation level by pressing the power level button on the study device however they will be blinded to which device they are using Study participants will be asked to use the devices whenever they are having a symptom of vertigo Each participant will be asked to record hisher level of vertigo in the online Study Diary before putting on the device after wearing the device for 5 minutes after removing the device
The study devices will record the following information regarding usage Date and time when the device is turned onoff and the power level Date and time when the power level is changed and the new power level
Participants will be allowed to use the device as long as they are getting benefit from the device at any power setting that they select Participants will be asked to complete an entry in the Study Diary even on days on which they do not experience a vertigo episode
The study coordinator will schedule six study monitoring call with each participant as close as possible to the following schedule
Call 1 Device I 4 days after enrollment Call 2 Device I 9 days after enrollment Call 3 Device I 14 days after enrollment Call 4 Device II 17 days after enrollment Call 5 Device II 22 days after enrollment Call 6 Device II 27 days after enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None