Background: Sleep impairment is common in patients after acute ischemic stroke (AIS) but few studies have examined the associated predictor variables and prognostic significance. Aims: To determine the factors associated with sleep impairment in patients with mild to moderate AIS who participated in the main Optimal Post rTpa-IV Monitoring in Ischemic Stroke Trial (OPTIMISTmain). Methods: OPTIMISTmain was an international, multicenter, stepped wedge, cluster randomized non-inferiority controlled trial with blinded outcome assessment, that aimed to determine the safety and effectiveness of low-intensity versus standard monitoring in stable thrombolysis-treated AIS patients. Sleep-related impairment was assessed at 7 days with an eight-item short-form questionnaire referred to as The Patient-Reported Outcome Measurement Information System (PROMIS). The primary outcome was unfavorable functional recovery (mRS 2-6) at 90 days. Secondary outcomes include death; death or dependency (mRS 3-6) and EQ-5D-5L visual analogue scale score. Total raw scores were converted to T-score , where >50 (mean for US general population) indicated sleep-related impairment. Analysis used logistic or linear regression models with adjustment for study design and potential confounders (P<0.2 in univariate analysis). Results: Of 4922 OPTIMISTmain participants, 3078 (62.5%) completed the PROMIS scale for a valid T-score (mean 46.1, SD 9.4), and 1242 (40.3%) had sleep impairment. Patients with sleep impairment were more likely female, non-Asian, and smokers, with a history of heart disease or hypercholesterolemia, and a greater neurological impairment (Table 1). From multivariable analysis (Table 2), female (p=0.0052), non-Asian (0.0042), and stroke severity on NIHSS (<0.0001) were independently associated with sleep impairment. Sleep impairment was associated with unfavorable functional recovery (adjusted odds ratio aOR 2.18, 95% CI 1.80-2.65, p<0.0001; Table 3), death or dependency (aOR 2.72, 95% CI 2.11-3.50, p<0.0001) and worse health quality of life (adjusted mean difference -5.35, 95% CI-6.58 to -4.12, p<0.0001). Conclusions: Sleep impairment is associated with poor outcomes in thrombolysis-treated patients with mild-to-moderate AIS. Sex, ethnicity and stroke severity were independently associated with sleep impairment after AIS.
Ouyang et al. (2026) studied this question.