Efficacy and Safety Evaluation of Remote Ischemic Adaptation ( Intermittent Pressure Stimulation ) in the Treatment of Insomnia After Stroke

NCT07401784 | Not Yet Recruiting FDA Device

• 1 other identifier: IIT-I-2025-045
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The incidence of post-stroke depression is high, which will affect the rehabilitation of neurological function, damage cognitive function, and increase the risk of subsequent stroke recurrence. The guidelines recommend that in addition to antiplatelet, blood pressure control, lipid-lowering and other treatments, secondary prevention of post-stroke depression should also be strengthened. Moreover, after the occurrence of post-stroke depression, methods such as medication and psychotherapy have their own limitations, such as potential adverse drug reactions and limited psychotherapy. Therefore, it is necessary to pay attention to the prevention of post-stroke depression. The remote ischemic adaptation therapy applied in our study is a safe, non-invasive and convenient physical therapy. By transiently and repeatedly applying ischemia-reperfusion stimulation to both upper arms, it induces a systemic protective response, improves the brain 's tolerance to ischemia and hypoxia, and exerts a protective effect on multiple organs such as the brain and heart. The RIC therapeutic instrument has been national patented and has been maturely applied to the prevention and treatment of acute cerebral infarction, which can promote the rehabilitation of neurological function. In addition, it also has certain curative effect in the treatment of cerebrovascular stenosis, refractory hypertension, depression, insomnia, anxiety and so on.

Conditions

Cerebral Apoplexy; Depression Anxiety Disorder; Cerebrovascular Disease

Keywords

Remote ischemic adaptation technology; cerebral apoplexy; Depression Anxiety Disorder; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• Sleep efficiency as measured by polysomnography

  Sleep efficiency is calculated as (total sleep time / total time in bed) × 100%, assessed by overnight polysomnography. Higher percentage indicates better sleep efficiency.

  4 weeks

• Insomnia Severity Index (ISI) total score

  The Insomnia Severity Index is a 7-item self-report questionnaire assessing perceived insomnia severity. Each item is rated on a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate more severe insomnia.

  4 weeks

Secondary Outcomes (12)

• Pittsburgh Sleep Quality Index (PSQI) global score

  4 weeks, 3 months, 6 months

• Change from baseline in sleep onset latency (SOL) as measured by polysomnography

  4 weeks

• Change from baseline in total sleep time (TST) as measured by polysomnography

  4 weeks

• Change from baseline in percentage of stage N1 sleep (N1%) as measured by polysomnography

  4 weeks

• Change from baseline in percentage of stage N2 sleep (N2%) as measured by polysomnography

  4 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

The full-automatic ischemic preconditioning therapeutic instrument was used to pressurize the patients ' upper arms ( experimental group pressure = 200 mmHg ) for 5 minutes, and then breathe out for 5 minutes, which was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, once in the morning and once in the afternoon, twice a day, at least 5 days a week, for a total of 4 weeks.

Device: Automatic ischemic preconditioning therapeutic apparatus

control group

SHAM COMPARATOR

Participants in this group will use a sham training device that is identical in appearance, sound, and sense of wear to the experimental device. The treatment plan was consistent with the experimental group in time and process : wearing a cuff for 5 minutes, rest for 5 minutes, a total of 5 cycles. The key difference is that during the so-called ' pressure ', the cuff is inflated to a pressure of only 60 mmHg to simulate the sense of operation of the device and a slight sense of skin contact. The treatment frequency, cycle and execution personnel were the same as those of the experimental group.

Device: Sham Ischemic Preconditioning Device

Interventions

Automatic ischemic preconditioning therapeutic apparatus DEVICE

The patient 's upper arms were pressurized for 5 minutes( Test group pressure = 200 mmHg ), and then breathed for 5 minutes. It was an ischemia-reperfusion cycle. Each training was performed for 5 consecutive cycles, 1 in the morning and 1 in the afternoon, 2 times / day, at least 5 days a week, for a total of 4 weeks.

treatment group

Sham Ischemic Preconditioning Device DEVICE

A sham training device that is identical in appearance, sound, and wear sensation to the experimental device. During the "pressure" phase, the cuff is inflated to a non-ischemic low pressure (60 mmHg) to mimic device operation. The treatment schedule (cycles, frequency, duration) is identical to the experimental arm.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old ;
• In line with the diagnostic criteria of ischemic stroke, with reference to the ' Chinese guidelines for the diagnosis and treatment of acute ischemic stroke ' diagnosed ischemic stroke ;
• Despite adequate sleep opportunities, patients still have difficulty in falling asleep or maintaining sleep, staying asleep at least 3 times a week for at least 3 months, which leads to pain or impaired daytime function.
• PSQI score ≥ 6 and ISI score ≥ 8 ;
• All research contents have been understood and informed consent has been signed.

You may not qualify if:

• Insomnia before stroke ;
• Patients with mental disorders, bipolar disorder or depression, generalized anxiety disorder and other mental disorders ;
• Patients were pregnant or lactating women ;
• Other reasons identified by the researchers are not suitable for patients ;

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Liang Xie

CONTACT

+86 18679162717; Ndefy14067@ncu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 10, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share