Trial Outcomes & Findings for Effects of Lifestyle Modification on Vestibular Migraine (NCT NCT03979677)
NCT ID: NCT03979677
Last Updated: 2021-08-17
Results Overview
This measure assesses disease-specific (headache) health-related quality of life using a 0 - 100 scale with 0 indicative of no impact and 100 indicative of severe maximum impact. We will assess change in HDI score by comparing baseline performance to performance 60-days after intervention.
COMPLETED
NA
41 participants
Change in HDI total score will be determined 60-days post intervention.
2021-08-17
Participant Flow
Participant milestones
| Measure |
Single Lifestyle Modification Intervention Group
Participants were recruited from patients seen for consultation for dizziness and/or imbalance in the John S. Odess Otolaryngology and Head and Neck Surgery Clinic. Consultations were provided by two nurse practitioners and one otolaryngologist. All clinicians were experienced in diagnosis and management of dizziness and imbalance including VM. All adult patients diagnosed with definite VM using the consensus criteria4 were eligible for inclusion. Patients who were determined to need pharmacological management at initial consultation were excluded.
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|---|---|
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Overall Study
STARTED
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41
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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13
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Lifestyle Modification Intervention Group
n=28 Participants
Participants were recruited from patients seen for consultation for dizziness and/or imbalance in the John S. Odess Otolaryngology and Head and Neck Surgery Clinic. Consultations were provided by two nurse practitioners and one otolaryngologist. All clinicians were experienced in diagnosis and management of dizziness and imbalance including VM. All adult patients diagnosed with definite VM using the consensus criteria4 were eligible for inclusion. Patients who were determined to need pharmacological management at initial consultation were excluded.
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|---|---|
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Age, Continuous
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46.4 years
STANDARD_DEVIATION 16 • n=28 Participants
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Sex: Female, Male
Female
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22 Participants
n=28 Participants
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Sex: Female, Male
Male
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6 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Change in HDI total score will be determined 60-days post intervention.This measure assesses disease-specific (headache) health-related quality of life using a 0 - 100 scale with 0 indicative of no impact and 100 indicative of severe maximum impact. We will assess change in HDI score by comparing baseline performance to performance 60-days after intervention.
Outcome measures
| Measure |
Intervention Group
n=28 Participants
All participants will be provided written and verbal instructions regarding the lifestyle modification intervention.
Lifestyle Modifications: Written suggestions on common migraine triggering food/beverages to avoid, restful sleep tips, exercise suggestions, and eating set mealtimes will be provided as the intervention.
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|---|---|
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Headache Disability Inventory (HDI)
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14.3 score on a scale
Interval 8.94 to 19.67
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PRIMARY outcome
Timeframe: Change in DHI total score will be determined 60-days post intervention.This measure assesses disease-specific (dizziness) health-related quality of life using a 0 - 100 scale with 0 indicative of no impact and 100 indicative of severe maximum impact.We will assess change in DHI score by comparing baseline performance to performance 60-days post-intervention.
Outcome measures
| Measure |
Intervention Group
n=28 Participants
All participants will be provided written and verbal instructions regarding the lifestyle modification intervention.
Lifestyle Modifications: Written suggestions on common migraine triggering food/beverages to avoid, restful sleep tips, exercise suggestions, and eating set mealtimes will be provided as the intervention.
|
|---|---|
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Dizziness Handicap Inventory (DHI)
|
14.3 score on a scale
Interval 8.94 to 19.67
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Adverse Events
Single Lifestyle Modification Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard A. Roberts, Ph.D.
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place