InsomniaRIC-A2AR-SDNCT07874594
Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders
A study testing RIC Intervention Group in people with Insomnia and Ischemic Stroke, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia, Ischemic Stroke, Sleep Wake Disorders
- What is being tested?
- RIC Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xian Wang, MD, +86-028-8739-3435, cowangxian@163.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Insomnia, Ischemic Stroke, Sleep Wake Disorders
- Being tested
- RIC Intervention Group, Sham Control Group
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Ischemic Stroke, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIC Intervention GroupDevice
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 Control GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RIC Intervention Group | Experimental | 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. Receives: Device: RIC Intervention Group |
| Sham Control Group | Sham comparator | 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. Receives: Device: Sham Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 90 days after treatment initiation.
Secondary outcomes (2)
PSQI Response Rate at 90 Days
Proportion of participants with a decrease of ≥5 points in PSQI score from baseline to 90 days.
Measured: Baseline and 90 days.
Insomnia Severity Index (ISI) Remission Rate at 90 Days
Proportion of participants with ISI score <8 at 90 days.
Measured: 90 days after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874594
- Sponsor's protocol ID
- IRB No. 619-1 (2026)
- Acronym
- RIC-A2AR-SD
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of Adenosine A2A Receptor-Mediated Neuroinflammation in the Alleviation of Post-Stroke Sleep Disorders by Remote Ischemic Conditioning
- ClinicalTrials.gov ID
- NCT07874594
- Acronym / sponsor ID
- RIC-A2AR-SD / IRB No. 619-1 (2026)
- Conditions
- Insomnia, Ischemic Stroke, Sleep Wake Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC Intervention Group | Experimental | Device: RIC Intervention GroupRemote 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. |
| Sham Control Group | Sham comparator | Device: Sham Control GroupSham 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIC Intervention GroupIschemic 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). | Device | RIC Intervention Group |
| Sham Control GroupSham 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. | Device | Sham Control Group |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) Score at 90 Days
Time frame: 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.
2 secondary outcomes
PSQI Response Rate at 90 Days
Time frame: Baseline and 90 days.
Insomnia Severity Index (ISI) Remission Rate at 90 Days
Time frame: 90 days after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC Intervention Group in people with Insomnia and Ischemic Stroke, run by Sichuan Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xian Wang (+86-132-6908-7917, cowangxian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) Score at 90 Days (time frame: Baseline and 90 days after treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.