Migraine Sleep Study (MiSleepS): The Role of Sleep and Stress as Triggers in Migraine - A Prospective Study on Sex and Gender Differences

Background Migraine affects over one billion people globally and is a major cause of disability, especially among women. Despite new therapies, treatment responses remain inconsistent, often overlooking individual factors such as sleep, stress, sex, and gender. Sleep disturbances, particularly insomnia, are frequently reported among migraine patients, yet their predictive role and bidirectional relationship with migraine remain unclear. Objectives Primary: Assess whether a personalized behavioral intervention targeting sleep and stress reduces migraine burden. Secondary: Identify predictors of migraine onset and severity, analyze sex- and gender-specific effects, evaluate how migraine impacts sleep, and monitor changes in sleep and stress post-intervention. Methods This is a prospective, two-phase study enrolling 80 adults with episodic migraine. Phase A (5 weeks): observation using a wearable device and app-based questionnaires. Phase B (6 weeks): personalized non-pharmacological intervention targeting sleep and stress. Questionnaires and wearable data assess sleep quality, circadian rhythms, stress, and migraine characteristics. Inclusion of the first participant is expected in January 2026. Expected Results We expect a ≥30% reduction in monthly migraine days post-intervention. Correlations between sleep, stress, and migraine patterns are anticipated, with distinct sex- and gender-specific differences in predictors and treatment effects. Impact This study aims to advance personalized migraine care by integrating real-world data on sleep and stress. Findings may guide tailored, non-pharmacological interventions and promote a more inclusive understanding of sex and gender differences in migraine management.