No phaseRecruiting
Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders (RIC-A2AR-SD)
The Role and Mechanism of Adenosine A2A Receptor-Mediated Neuroinflammation in the Alleviation of Post-Stroke Sleep Disorders by Remote Ischemic Conditioning
- Sponsor
- Sichuan Academy of Medical Sciences (Academic or other)
- Enrollment
- 136 planned
- Conditions
- Insomnia; Ischemic Stroke; Sleep Wake Disorders
- Interventions
- RIC Intervention Group; Sham Control Group
- Ages
- adults, older adults
- Registry
- NCT07874594
Full record on ClinicalTrials.gov
From the registry
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,…
Primary outcomes
- Pittsburgh Sleep Quality Index (PSQI) Score at 90 Days
History
Study completion expected
Primary completion expected
Registered
Started