Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

RIC Intervention Group: Ischemic preconditioning training device (Model: IPC-906M). Applied to bilateral upper limbs, twice daily for 90 days, with a cuff pressure of 220 mmHg. Each session: 5 min ischemia/5 min reperfusion, 5 cycles (total 45 min).

Sham Control Group: Sham ischemic preconditioning device with the same specifications as the RIC device, applied to bilateral upper limbs twice daily for 90 days. Each session: 5 min ischemia/5 min reperfusion, 5 cycles (total 45 min), with a cuff pressure of 60 mmHg.

Study summary

This is a single-center, prospective, randomized, double-blind, sham-controlled study. It will test whether remote ischemic conditioning (RIC), a non-invasive arm-cuff treatment, can improve insomnia after ischemic stroke and whether adenosine A2A receptors and neuroinflammation are involved.

About 136 patients will be enrolled. Eligible participants are 18-80 years old, right-handed, have had a first imaging-confirmed ischemic stroke 3-6 months earlier, have an mRS score ≤3, and report insomnia with a PSQI score \>5. Patients with other sleep disorders, severe medical conditions, or recent use of sleep-affecting medications will be excluded.

Participants will be randomly assigned to RIC (cuff pressure 200 mmHg) or sham control (60 mmHg). Both groups will receive treatment twice daily for 90 days. Each session lasts 45 minutes and includes 5 cycles of 5-minute ischemia and 5-minute reperfusion.

The primary outcome is the PSQI score at 90 days. Secondary outcomes include PSQI response (≥5-point decrease), insomnia remission (ISI \<8), polysomnographic sleep measures, fatigue, daytime sleepiness, mood, quality of life, blood inflammatory markers, and A2A receptor expression on monocytes. Follow-up will occur at 1, 2, 3, 6, and 12 months.

This study may determine whether RIC is a safe, non-drug option for post-stroke insomnia and help clarify its anti-neuroinflammatory mechanism.

Eligibility

Primary outcome measure(s)

• Pittsburgh Sleep Quality Index (PSQI) Score at 90 Days — Baseline and 90 days after treatment initiation.
  Global PSQI score at 90 days after initiation of remote ischemic conditioning (RIC) or sham treatment. The PSQI is a self-reported questionnaire assessing sleep quality over the past month; scores range from 0 to 21, with higher scores indicating worse sleep quality. Time Frame: Baseline and 90 days after treatment initiation.

Trial sites (1)

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