An interventional study of RIC Intervention Group and Sham Control Group in Insomnia, Ischemic Stroke and Sleep Wake Disorders, sponsored by Sichuan Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Sichuan Academy of Medical Sciences · Not applicable, Interventional, and Treatment
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's planned enrollment of 136 is above the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Sichuan Academy of Medical Sciences is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Remote ischemic conditioning (RIC) applied twice daily for 90 days. Each session consists of 5 cycles of 5-min ischemia followed by 5-min reperfusion, with a cuff pressure of 220 mmHg.
Device: RIC Intervention Group
Sham intervention applied twice daily for 90 days. Each session consists of 5 cycles of 5-min ischemia followed by 5-min reperfusion, with a cuff pressure of 60 mmHg.
Device: Sham Control 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 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.
Pittsburgh Sleep Quality Index (PSQI) Score at 90 Days
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.
Time frame: Baseline and 90 days after treatment initiation.
PSQI Response Rate at 90 Days
Proportion of participants with a decrease of ≥5 points in PSQI score from baseline to 90 days.
Time frame: Baseline and 90 days.
Insomnia Severity Index (ISI) Remission Rate at 90 Days
Proportion of participants with ISI score \<8 at 90 days.
Time frame: 90 days after treatment initiation.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months and ending 36 months following article publication.
Access criteria: Access will be granted to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement and obtain approval from the relevant ethics committee.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.
Of 825 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 27 months is above that.
Counting every sponsor, half of 883 studies reached it within 19 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sichuan Academy of Medical Sciences