NCT07874594Recruiting
Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders
The Role and Mechanism of Adenosine A2A Receptor-Mediated Neuroinflammation in the Alleviation of Post-Stroke Sleep Disorders by Remote Ischemic Conditioning
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Diseases
- Stroke
- NCT number
- NCT07874594
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 1 Sept 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.