Insomnia, Ischemic Stroke, Sleep Wake Disorders
Conditions
Brief 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.
Interventions
DEVICERIC 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).
DEVICESham 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.
Sponsors
Sichuan Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years. * Right-handed. * First-ever stroke, with imaging-confirmed ischemic cerebral infarction. * Receiving routine treatment for ischemic stroke. * Time since stroke onset: 3 months ≤ onset time ≤ 6 months. * Modified Rankin Scale (mRS) score ≤3. * Presence of insomnia complaints, defined as Pittsburgh Sleep Quality Index (PSQI) score \>5.
Exclusion criteria
* Diagnosis of chronic insomnia within 3 months before stroke onset, or a history of other sleep disorders. * Presence of significant manifestations of sleep apnea. * Concomitant other neuropsychiatric disorders. * Concomitant severe somatic diseases, such as acute illness or infectious diseases. * Use of medications that affect sleep within 2 weeks before enrollment. * History of shift work or jet lag within 4 months before enrollment, or planned shift work or jet lag within 3 months after enrollment. * Pregnant or breastfeeding women. * History of alcohol abuse or psychoactive substance use within the past year. * Inability to complete CT, MRI, or other imaging examinations. * Body mass index (BMI) ≥35 kg/m². * Current participation in another clinical trial. * Dementia, aphasia, or other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSQI Response Rate at 90 Days | Baseline and 90 days. | Proportion of participants with a decrease of ≥5 points in PSQI score from baseline to 90 days. |
| Insomnia Severity Index (ISI) Remission Rate at 90 Days | 90 days after treatment initiation. | Proportion of participants with ISI score \<8 at 90 days. |
Countries
China
Contacts
CONTACTXian Wang
Outcome results
None listed