N/A
N=100
Smell Sensitivity in Chronic Migraine: A Case-Control Study
Chronic Migraine · Olfactory Acuity
Bottom Line
View on ClinicalTrials.gov: NCT01687088 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points — 34.5; 35.9; 34.7; 36.1 UPSIT Score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points |
34.5; 35.9; 34.7; 36.1 | — |
Summary
Olfactory impairment is a common symptom of neurologic disorders and may be related to dopaminergic dysfunction. Studies show that patients with migraine show increased sensitivity to light and sound. In our previous study in episodic migraineurs, olfaction was similar to age and sex-matched controls outside of attacks, but lower during acute attacks.
The hypothesis is that olfactory function in chronic migraine (CM) will have mild impairment of olfaction at baseline but a more significant impairment during migraine or headache exacerbations.
The investigators have two objectives:
* To determine baseline olfactory acuity in subjects with CM and compare them to age and sex-matched controls
* To determine how olfaction changes during acute exacerbations of migraine in those with CM
To execute this study, the investigators will interview subjects and controls to ensure that they meet inclusion and exclusion criteria. After obtaining informed consent, subjects and controls will complete a questionnaire survey regarding their history or lack of history of headaches, smell sensitivity, osmophobia and current medication use and answer questions about attack frequency, location of headache, duration of disease, use of medication for pain, and disability. Both migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office.
After the first visit, migraineurs and controls will self-administer the UPSIT at home. They will be required to return the second test to the Jefferson Headache Center.
The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores between subjects and controls. To achieve a 90% power that the study will detect a statistically significant difference between the mean UPSIT scores at a two-sided 5 percent significance level, our sample size for both subjects and controls is 50.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects over the age of 18 with Chronic Migraine (>15 headache days/month, at least 8 days meet criteria for migraine)
Exclusion Criteria
- Subjects with sinus/nasal disease
- Subjects with a history of head trauma or degenerative disease
- Subjects who are decisionally impaired.
- Controls will be age and sex-matched with no history of migraine. They cannot have any disability from headache as determined by the MIDAS (Migraine Disability Assessment) questionnaire. Only controls with a MIDAS score of "0" (no disability) will be allowed in the study.
Data sourced from ClinicalTrials.gov (NCT01687088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.