Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267924
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-12
Brief Title:
SENSE-VM Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
Sponsor:
Otolith Labs
Organization:
Otolith Labs
Study Overview
Official Title:
SENSE-VM Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
Status:
RECRUITING
Status Verified Date:
2024-08
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 compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines VM also known as Migraine Associated Vertigo
Participants will be
Enrolled up to 50 days enrollment 14 days in Baseline Phase no device 7 days in Transition Phase 28 days in Treatment Phase study device
Randomized and stratified into groups based on the referring clinic to be assigned one study device
Asked to use the study device as instructed by the study coordinator
Asked to submit daily diaries reporting 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 determine which group responds better to which device
Participants will be
Enrolled up to 50 days enrollment 14 days in Baseline Phase no device 7 days in Transition Phase 28 days in Treatment Phase study device
Randomized and stratified into groups based on the referring clinic to be assigned one study device
Asked to use the study device as instructed by the study coordinator
Asked to submit daily diaries reporting 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 determine which group responds better to which device
Detailed Description:
This study is a decentralized clinical trial This study uses technology and virtual meetings to communicate with study participants and collect study data This study seeks to enroll until 200 participants have completed the study per protocol
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 a 14 day Baseline Phase
If a participant is eligible to remain in the study for the Treatment Phase at day 15 they will be randomized within their assigned group at a 11 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 50 days with virtual meetings at the approximate intervals
Day 15 Day 22 Day 25 Day 35 and Day 50
Participants will be required to complete the DHI Dizziness Handicap Inventory VM-PATHI Vestibular Migraine Patient Assessment Tool and Handicap Inventory General Vertigo History Global Impression of Change Most Bothersome Symptom Relief from Most Bothersome Symptom and Net promoter score questionnaires
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021
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 a 14 day Baseline Phase
If a participant is eligible to remain in the study for the Treatment Phase at day 15 they will be randomized within their assigned group at a 11 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 50 days with virtual meetings at the approximate intervals
Day 15 Day 22 Day 25 Day 35 and Day 50
Participants will be required to complete the DHI Dizziness Handicap Inventory VM-PATHI Vestibular Migraine Patient Assessment Tool and Handicap Inventory General Vertigo History Global Impression of Change Most Bothersome Symptom Relief from Most Bothersome Symptom and Net promoter score 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