DOI: 10.4103/bc.bc_70_26 ISSN: 2394-8108

Effects of remote ischemic conditioning on sleep function in patients during stroke rehabilitation: A multicenter randomized controlled pilot study

Yunqian Luo, Liang Chu, Yiyi Li, Li Xiong, Wenyu Lu, Jiamin Chen, Alexander Weiss, Sydni Rosenfeld, Xintong Wu, Zhen Chen
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Abstract:

BACKGROUND:

Remote ischemic conditioning (RIC) is a simple, low-cost, and safe intervention. Clinical evidence regarding its effects on sleep disturbances and related psychological symptoms during the poststroke rehabilitation phase remains limited. This pilot study evaluated the feasibility and clinical effects of RIC in this population.

METHODS:

In this multicenter, randomized, double-blind, sham-controlled pilot trial, patients undergoing poststroke rehabilitation with comorbid sleep disturbances were randomized to receive either RIC or a sham intervention for 2 weeks. As a pilot trial, no single primary outcome was prospectively designated; all endpoints were considered exploratory and were intended to generate preliminary effect estimates to inform future confirmatory studies. Objective sleep parameters were obtained using a portable monitoring system, and subjective sleep and psychological outcomes were evaluated using validated questionnaires. Between-group comparisons were performed on change from baseline values, and safety was monitored throughout the study.

RESULTS:

Sixty patients completed the study (30 RIC, 30 sham-RIC). Compared with the Sham group, the RIC group exhibited a greater reduction in nocturnal awakenings ( P < 0.001) and mean hypopnea duration ( P = 0.041). Reductions in Insomnia Severity Index, Zung Self-Rating Anxiety Scale, and Zung Self-Rating Depression Scale scores were also greater in the RIC group (all P < 0.05), No between-group differences were observed in total Pittsburgh Sleep Quality Index scores, sleep architecture parameters, or heart rate variability indices. No serious RIC-related adverse events occurred.

CONCLUSIONS:

A 2-week RIC intervention was safe and well-tolerated and was associated with improvements in sleep continuity and mood-related symptoms in stroke patients undergoing rehabilitation, without short-term changes in overall sleep architecture. Given the exploratory pilot design and the limited sample, these findings should be interpreted as preliminary signal estimates that support feasibility and justify evaluation in larger adequately-powered randomized trials.

TRIAL REGISTRATION:

www.chictr.org.cn (identifier: ChiCTR2600128371).

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