Yingjie Che, Ranwei Yao, Dan Chen, Xiulin Wu
This multimodal sleep intervention showed preliminary signals of improvements in subjective sleep quality and selected objective sleep architecture parameters, suggesting feasibility and tolerability in patients with refractory chronic insomnia and appeared to be generally well tolerated. Given the exploratory single-arm design and limited sample size, randomized controlled studies are required to further evaluate efficacy, durability, and the relative contribution of individual treatment components.
BACKGROUND: Chronic insomnia is increasingly recognized as a disorder of persistent hyperarousal, and current single-modality treatments often provide limited or unsustained benefits. This study aimed to explore the feasibility, safety, and preliminary signal of benefit of a multimodal sleep intervention combining stellate ganglion block (SGB), cognitive behavioral therapy for insomnia (CBT-I), and anesthetic-assisted sleep induction.
METHODS: In this prospective exploratory pilot study, 30 patients with refractory chronic insomnia who showed inadequate response to conventional therapies were enrolled. The intervention consisted of SGB, CBT-I, and propofol- and dexmedetomidine-assisted sleep induction. Subjective sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline and at 7 days, 1 month, 3 months, and 6 months after treatment. Objective sleep parameters were evaluated using a wearable sleep monitoring device. Repeated measures were analyzed using generalized estimating equations.
RESULTS: PSQI total and component scores were significantly reduced at all follow-up time points compared with baseline (all p < 0.05). The mean reduction in PSQI total score was approximately 8 points. Notably, the proportions of deep sleep and REM sleep increased significantly despite minimal changes in total sleep time (both p < 0.05). No serious adverse events were observed during the study period.
CONCLUSION: This multimodal sleep intervention showed preliminary signals of improvements in subjective sleep quality and selected objective sleep architecture parameters, suggesting feasibility and tolerability in patients with refractory chronic insomnia and appeared to be generally well tolerated. Given the exploratory single-arm design and limited sample size, randomized controlled studies are required to further evaluate efficacy, durability, and the relative contribution of individual treatment components.
CLINICAL TRIAL NUMBER: https://www.chictr.org.cn, ChiCTR2400085256.