Effects of Lifestyle Modification on Vestibular Migraine

NCT03979677 | Completed Results

• 1 other identifier: 2019-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular migraine was recently addressed by the International Headache Society (IHS) as separate from other types of migraine. Vestibular migraine is one of the most common causes of vertigo attacks, affecting 1-5% of people. People with vestibular migraine have lower quality of life compared to others and some are completely debilitated by their symptoms. Symptoms include vertigo, nausea, head motion-induced dizziness, unsteadiness, balance problems, and lightheadedness. Most reports of vestibular migraine management have focused on treatment with medications; however, recommendations also include some form of lifestyle modification. Lifestyle modifications like avoidance of certain foods, improving sleep, exercising, etc. have all been reported to help migraine in general, but there are no reports on the effects of lifestyle modification on vestibular migraine as defined by IHS. It is important to investigate the effects of lifestyle modifications on vestibular migraine because the underlying causes of vestibular migraine are unclear. So, it is also unclear if lifestyle modifications are effective for vestibular migraine. Many investigations of lifestyle modification on migraine include a single modification like diet, weight loss, or sleep. Our modifications include food triggers, restful sleep, exercise, and eating regularity. We hypothesize comprehensive lifestyle modifications will improve symptoms of vestibular migraine. We will measure how people feel dizziness and headache activity is affecting their lives before and after our intervention. This project is important because vestibular migraine is reported to be the one of the most common causes of vertigo and interventions useful for other migraine types may not be effective for vestibular migraine. If we demonstrate improvement with comprehensive lifestyle modifications, we will continue the line of investigation with randomized, controlled studies. This work furthers our goal of helping the many people impacted by vestibular migraine.

Conditions

Vestibular Migraine

Keywords

vestibular migraine, dizziness, vertigo

Outcome Measures

Primary Outcomes (2)

• Headache Disability Inventory (HDI)

  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.

  Change in HDI total score will be determined 60-days post intervention.

• Dizziness Handicap Inventory (DHI)

  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.

  Change in DHI total score will be determined 60-days post intervention.

Study Arms (1)

Intervention Group

EXPERIMENTAL

All participants will be provided written and verbal instructions regarding the lifestyle modification intervention.

Behavioral: Lifestyle Modifications

Interventions

Lifestyle Modifications BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years and older)
• Must meet International Classification of Headache Disorders criteria for vestibular migraine
• Must be able to read and comprehend the English language as instructions are only provided in that language

You may not qualify if:

• Younger than 18 years
• Do not meet IHCD criteria for vestibular migraine
• Unable to understand English language instructions

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Roberts RA, Watford KE, Picou EM, Hatton K, Trone TH, Brignola EY. Effects of Lifestyle Modification on Vestibular Migraine. Otol Neurotol. 2021 Dec 1;42(10):e1537-e1543. doi: 10.1097/MAO.0000000000003297.

  PMID: 34325453 DERIVED

MeSH Terms

Conditions

Dizziness; Vertigo

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Limitations and Caveats

The current study is limited by lack of a control group. Future investigations could incorporate crossover interventions to compare effects of no intervention to lifestyle modification, pharmacological intervention, and combinations. Another limitation is that we relied solely on patient report to determine intervention compliance.

Results Point of Contact

• Title: Richard A. Roberts, Ph.D.
• Organization: Vanderbilt University Medical Center

richard.a.roberts@vanderbilt.edu

6153227384

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Eligible participants will receive information on food/beverage triggers to avoid, restful sleep tips, simple exercise tips, and eating regularly at the same time. Participants will return after 60 days and both pre- and post-intervention measures will be obtained.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: October 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)