Arm-Cuff Treatment for Sleep Problems After Ischemic Stroke
Tests a repeated arm-cuff treatment for insomnia in people after ischemic stroke.
Plain-language title generated from the registry record
Registry title: Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders
Key facts
- Where
- Chengdu, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07874594, who can take part
Where in China
- Sichuan Academy of Medical Sciences sichuan Provincial People's HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Academy of Medical Sciences
- Trial code
- NCT07874594
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
The Role and Mechanism of Adenosine A2A Receptor-Mediated Neuroinflammation in the Alleviation of Post-Stroke Sleep Disorders by Remote Ischemic Conditioning
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.
Inclusion: 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: Diagnosis of chronic insomnia within 3 months before stroke onset, or a history of other sleep disorders; 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; History of alcohol abuse or psychoactive substance use within the past year; Dementia, aphasia, or other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment; Presence of significant manifestations of sleep apnea; Pregnant or breastfeeding women; Inability to complete CT, MRI, or other imaging examinations; Body mass index (BMI) ≥35 kg/m²; Current participation in another clinical trial.