Olfactory Acuity in Chronic Migraine: A Case-Control Study
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveCas témoins
Analyse de profils avec et sans la maladie pour comprendre ce qui pourrait l'avoir favorisée.Résumé
Date de début de l'étude : 1 juillet 2011
Date à laquelle le premier participant a commencé l'étude.The investigators will interview subjects and controls to ensure that they meet inclusion criteria and do not meet exclusion criteria. After obtaining informed consent, subjects and controls will complete a questionnaire survey with the interviewer regarding their history of headaches, smell sensitivity, osmophobia and current medication use. Subjects will also answer questions about attack frequency, location of headache, duration of disease, use of medication for pain, and disability. After completing the questionnaire survey, migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. During this visit we will demonstrate and give instructions on how to perform UPSIT at home. After the first visit, migraineurs will self-administer the UPSIT during a migraine attack day at home. They will be required to mail or drop off the second test at the Jefferson Headache Center. Age and sex matched controls will take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home and call the Headache Center to notify the staff that they have completed the second UPSIT. They will be asked to mail or drop off the test at the Jefferson Headache Center. The UPSIT is a standardized, validated test for olfaction. There are a total of 40 odorants, with four booklets each containing ten odorants. The stimuli are embedded in "scratch and sniff" microcapsules at the bottom of each page. Subjects must choose one answer among four possible answers for each odorant - a forced choice test. The validity and reliability of the UPSIT, as well as the basis for using these particular odorants, has been demonstrated in multiple studies. The tests kits will be supplied by Dr. Richard Doty at University of Pennsylvania. The investigators will use analysis of variance (ANOVA) to determine variance in UPSIT scores between subjects and controls. We will also use ANOVA to examine differences based on subject characteristics, including attack frequency, duration of illness, osmophobia during attacks, and if odors trigger headaches. The investigators will also use Chi-square and the Wilcoxon rank sum test to determine categorical outcomes such as gender and statistical significance between groups. 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. This is based on the assumption that the standard deviation of the response variable is 3 units. The investigator's assumptions about effect size are based on previous studies using the UPSIT to detect differences in subjects and controls in other neurologic disorders, such as schizophrenia.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cas témoins
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux