Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787653
Status:
UNKNOWN
Last Update Posted:
2022-03-22
First Post:
2021-02-09
Brief Title:
Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
Sponsor:
Otolith Labs
Organization:
Otolith Labs
Study Overview
Official Title:
Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
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 proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their tinnitus The Study will be placebo controlled with each participant using an effective device for half of the enrollment period and a placebo device for half of the enrollment period The order of placebo and effective usage will be randomized and the researchers will be blinded to which device a participant is using Study participants will be instructed in an online telehealth conference on how to operate the OtoBand and how to wear the OtoBand Participants will be enrolled for approximately 30 days from Informed Consent to Wrap-up call
Detailed Description:
This study seeks to gather data on the effect of the OtoBand in participants who have reported symptoms of tinnitus 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 in-person contact in the study
Otolith Sound hereafter Otolith seeks to recruit study participants via several online channels including Facebook Google and their website httpsotolithlabscomtinnitustelehealthstudy Otolith will use online advertisements to inform potential participants about the study and ask them to volunteer for online screening and enrollment
Each participant will be enrolled in the study only after a successful video screening including agreement to participate After a participant is enrolled a device will be shipped to them via USPS or similar carrier The participant will be instructed not to open the shipping box with the device until their initial study call with the study coordinator
During the initial study call participants will be instructed on how to use the OtoBand and how to wear the device There will be a total of four online meetings with each study participant It is expected that a typical participant will be enrolled in the study for approximately 30 days - from consent to filling out the last questionnaire and online wrap up meeting In these 30 days the participant will be wearing a device for 30 minutes each day over the course of two times 5 days In addition to online study calls Sponsor will use email and text messaging to communicate with the participants For example if a study participant does not complete a study diary on a given day a text message will be sent reminding them to do so
After the enrollment period participants will be instructed to return the device in a pre-paid envelope The devices will stop functioning 20 days after the first use
Otolith Sound hereafter Otolith seeks to recruit study participants via several online channels including Facebook Google and their website httpsotolithlabscomtinnitustelehealthstudy Otolith will use online advertisements to inform potential participants about the study and ask them to volunteer for online screening and enrollment
Each participant will be enrolled in the study only after a successful video screening including agreement to participate After a participant is enrolled a device will be shipped to them via USPS or similar carrier The participant will be instructed not to open the shipping box with the device until their initial study call with the study coordinator
During the initial study call participants will be instructed on how to use the OtoBand and how to wear the device There will be a total of four online meetings with each study participant It is expected that a typical participant will be enrolled in the study for approximately 30 days - from consent to filling out the last questionnaire and online wrap up meeting In these 30 days the participant will be wearing a device for 30 minutes each day over the course of two times 5 days In addition to online study calls Sponsor will use email and text messaging to communicate with the participants For example if a study participant does not complete a study diary on a given day a text message will be sent reminding them to do so
After the enrollment period participants will be instructed to return the device in a pre-paid envelope The devices will stop functioning 20 days after the first use
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