The association between insomnia and migraine disability and quality of life: a secondary analysis of a randomized controlled trial

OBJECTIVE: People with migraine have a higher prevalence and severity of insomnia. We examined the relationship between insomnia severity and migraine-related disability (Migraine Disability Assessment [MIDAS]) and migraine-specific quality of life (Migraine-Specific Quality of Life Questionnaire [MSQv2.1]). METHODS: We conducted a post-hoc analysis of a pilot randomized controlled study assessing the RELAXaHEAD application in those with insomnia and comorbid migraine. Descriptive statistics were used to summarize demographic and clinical characteristics. Linear mixed model analysis was conducted to evaluate Insomnia Severity Index (ISI) as a predictor of each MSQv2.1 domain and MIDAS. RESULTS: Forty-two participants completed baseline and at least one follow-up survey. Mean age was 43.8 years (SD 12.6) and the majority (85.7%) were female. Most participants (81.0%) had severe migraine-related disability (median baseline MIDAS, 32; IQR 52). Over half (54.8%) of participants had moderate clinical insomnia (mean baseline ISI, 18.5; SD 4.6). Baseline median MSQv2.1 scores were 44.3 (IQR 31.4) for Role Function-Restrictive (RFR), 65.0 (IQR 45.0) for Role Function-Preventive (RFP), and 46.7 (IQR 46.7) for Emotional Function (EF). The effect of ISI on MIDAS was statistically significant (rate ratio [RR]=1.10, P < .05, 95% CI, 1.028-1.171, meaning each 1-point increase in ISI was associated with a 10% higher MIDAS score). Additionally, a 1-point increase in ISI was associated with a decrease of 1.2 points in MSQ-RFR (B=-1.205, P = .001), 1.0 point in MSQ-RFP (B=-0.981, P = .020), and 1.4 points in MSQ-EF (B=-1.66, P = .001). CONCLUSIONS: Our study revealed significant associations between insomnia severity and migraine-related disability and quality of life, highlighting the importance of prevention and sleep intervention for patients with migraine. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT05466682, https://clinicaltrials.gov/study/NCT05466682?cond=NCT05466682&rank=1.