Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand : Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
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 2:1 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 49Participants 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.
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 13. Feb. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: July 27, 2023, Last downloaded: ClinicalTrials.gov processed this data on February 21, 2024, Last updated: February 21, 2024 |
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| Study ID: |
NCT05960786 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG009372571 |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: July 27, 2023, Last downloaded: ClinicalTrials.gov processed this data on February 21, 2024, Last updated: February 21, 2024 | ||
| 520 | |a 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 2:1 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 49Participants 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 | ||
| 650 | 2 | |a Vertigo | |
| 650 | 2 | |a Meniere Disease | |
| 650 | 2 | |a Benign Paroxysmal Positional Vertigo | |
| 650 | 2 | |a Vestibular Diseases | |
| 650 | 2 | |a Dizziness | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
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