Go! to sleep ^SM: a randomized, controlled trial for the treatment of chronic insomnia in adults epilepsy

Insomnia is a prevalent, treatable comorbidity in adults with epilepsy (AWE). Cognitive Behavioral Therapy for Insomnia (CBTI) is the gold standard treatment for insomnia, but its effectiveness in AWE has not been extensively studied. We conducted a randomized, single-blind, controlled trial to evaluate the effectiveness of computerized CBTI (cCBTI) using the Go! To Sleep^SM program on sleep-related outcomes in AWE and, for the first time, explored its effect on seizure control.

AWE with moderate-to-severe insomnia were randomized to cCBTI or sleep hygiene education alone (control). The primary outcome was change in Insomnia Severity Index (ISI) from baseline to end of study (EOS). Secondary Patient-Reported Outcomes (PROs) included the Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Patient Sleep Quality Inventory (PSQI), Patient Health Questionnaire-9 (PHQ-9), self-reported sleep duration, and frequency of disabling seizures.

Thirty-five subjects (mean age 39.5 ± 12.6 years; 57 % female) were analyzed. ISI scores decreased in both groups beyond the clinically meaningful threshold of 4 points (-9.0 with cCBTI vs. - 5.8 with control; both p < 0.001); the between-group difference was not significant (p = 0.076). All PROs improved in cCBTI, while controls showed improvement in ESS, FSS, and PSQI only. PHQ-9 (-4.5, p = 0.003) and sleep duration (+1.07 h, p < 0.001) improved significantly only in cCBTI. Seizure frequency, higher at baseline in cCBTI compared to controls (p = 0.028), was comparable by EOS (p = 0.30).

Both cCBTI and sleep hygiene significantly improved insomnia severity, daytime sleepiness, fatigue, and sleep quality. cCBTI was additionally associated with reduced depressive symptoms and increased sleep time. While no significant between-group difference in seizure frequency was observed, narrowing baseline differences suggests a potential benefit of cCBTI. Larger studies are warranted.