The safety and validity of remote ischemic preconditioning training on sleep disorder after stroke: a randomized controlled trial.

OBJECTIVE

To explore the safety and validity of remote ischemic preconditioning (RIPC) training in improving sleep quality, quality of life, and anxiety levels in individuals with post-stroke insomnia (PSI).

METHODS

A total of 86 stroke patients were randomly assigned to an intervention or control group. The control group received Routine nursing, while the intervention group received additional RIPC training twice a day for 10 days. Outcomes were assessed at baseline (T1), 1 week post-intervention (T2), and 3 months post-intervention (T3) using the Pittsburgh Sleep Quality Index (PSQI), Stroke-Specific Quality of Life Scale (SS-QOL), and Generalized Anxiety Disorder 7-item scale (GAD-7). Generalized estimating equations (GEE) were used to analyze the between-group differences across the three time points, with baseline as the reference. Adverse events during the intervention period were recorded, and compared between groups using Fisher's exact test or the chi-square test, as appropriate.

RESULTS

There was no statistically significant incidence of Adverse events between the two groups(p = 0.494). Compared to baseline, the intervention group showed significantly greater improvement in sleep quality (PSQI) than the control group at both T2 (β [95%CI]:-1.30[-1.83,-0.78], p < 0.001, Cohen's d = -0.51) and T3 (β [95%CI]:-1.81[-2.57, -1.06], p < 0.001, Cohen's d = -0.76). The SS-QOL also improved significantly in the intervention group at T2 (β[95%CI]:7.63[3.02,12.23], p = 0.001, Cohen's d = 0.49) and T3 (β[95%CI]: 8.12 [3.95,12.29], p < 0.001, Cohen's d = 0.55). Although the GAD-7 scores in the intervention group decreased, no significant between-group differences were observed at T2 (p = 0.056, d = -0.22) or T3 (p = 0.152, d = -0.31).

CONCLUSION

The 10-day RIPC intervention was well tolerated and significantly improved sleep quality and stroke-specific quality of life at 3-month follow-up, but did not significantly reduce anxiety symptoms. Larger sample sizes and longer follow-up periods are required to confirm these findings. This study was registered with the Chinese Clinical Trial Registry on July 26, 2024 (registration number: ChiCTR2400087429).