Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960786
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2023-05-18
Brief Title:
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Sponsor:
Otolith Labs
Organization:
Otolith Labs
Study Overview
Official Title:
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
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:
The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vertigo
The main questions it aims to answer are
Which device do participants respond better to that is find more relief
To what degree do participants find relief
Participants will be
Enrolled up to 49 days 14 days in Baseline Phase no device and 21 days in Treatment Phase study device for Study Arm 1 or 28 days in Treatment Phase study device for Study Arm 2
Randomized and stratified into groups based on diagnosis to be assigned a study device
Asked to use the study device as instructed by the study coordinator
Asked to download a study app to submit daily diaries regarding their symptoms and use of device and to participate in tele-health visits with study coordinators
Asked to provide their vertigo diagnosis from their physician
Compensated for their participation
Researchers will compare the randomized groups to see which groups respond better to which device
The main questions it aims to answer are
Which device do participants respond better to that is find more relief
To what degree do participants find relief
Participants will be
Enrolled up to 49 days 14 days in Baseline Phase no device and 21 days in Treatment Phase study device for Study Arm 1 or 28 days in Treatment Phase study device for Study Arm 2
Randomized and stratified into groups based on diagnosis to be assigned a study device
Asked to use the study device as instructed by the study coordinator
Asked to download a study app to submit daily diaries regarding their symptoms and use of device and to participate in tele-health visits with study coordinators
Asked to provide their vertigo diagnosis from their physician
Compensated for their participation
Researchers will compare the randomized groups to see which groups respond better to which device
Detailed Description:
This study is decentralized clinical trial This study uses technology and and virtual meetings to communicate with study participants and collect study data This study seeks to enroll until 36 participants in the MoW arm have completed the study and until 72 participants have completed the QoL arm
All study participants that meet all of the inclusion none of the exclusion criteria and sign informed consent will be enrolled in the study Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase
After the Baseline Phase participants will be placed in one of two groups Moderate or Worse MoW group or Quality of Life QoL group based on the data collected about their vertigo during the Baseline Phase
Participants will then be randomized within their assigned group MoW or QoL at a 21 ratio to an active arm or sham arm to begin the Treatment Phase of the study Participants will be sent a study device to use when they have a vertigo episode
Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals
MoW Group Day 21 Day 24 Day 31 and Day 42 QoL Group Day 16 Day 24 Day 36 and Day 49
Participants will be required to complete the DHI Dizziness Handicap Index VSS Vertigo Symptom Scale Global Impression of Symptoms and Global Impression of Change questionnaires
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021
All study participants that meet all of the inclusion none of the exclusion criteria and sign informed consent will be enrolled in the study Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase
After the Baseline Phase participants will be placed in one of two groups Moderate or Worse MoW group or Quality of Life QoL group based on the data collected about their vertigo during the Baseline Phase
Participants will then be randomized within their assigned group MoW or QoL at a 21 ratio to an active arm or sham arm to begin the Treatment Phase of the study Participants will be sent a study device to use when they have a vertigo episode
Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals
MoW Group Day 21 Day 24 Day 31 and Day 42 QoL Group Day 16 Day 24 Day 36 and Day 49
Participants will be required to complete the DHI Dizziness Handicap Index VSS Vertigo Symptom Scale Global Impression of Symptoms and Global Impression of Change questionnaires
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021
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?:
None
Is an FDA AA801 Violation?:
None