Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

NCT ID: NCT05289518

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-13

Brief Summary

This study intends to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.

Detailed Description

Sleep disturbance after stroke is an important factor affecting the prognosis of stroke function. At present, most studies have focused on the diagnosis and treatment of sleep disordered breathing after stroke, while stroke-related insomnia has been neglected. Therefore, it is of great significance to explore a treatment that combines stroke protection with sleep improvement.

Remote ischemic conditioning (RIC) triggers endogenous protective effect through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of autonomic nervous system, release of humoral factors, improvement of vascular endothelial function and modulation of immune/inflammatory responses, which participate in the regulation of sleep after stroke.Therefore, this study intends to conduct a randomized controlled trial to further reveal the effect of RIC in stroke-related insomnia and explore its potential mechanisms.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 3 months.

Group Type: EXPERIMENTAL

Remote ischemic conditioning (RIC)

Intervention Type: DEVICE

RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 220mmHg and 5-min deflation.

Sham control group

Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 3 months.

Group Type: SHAM_COMPARATOR

Sham remote ischemic conditioning (Sham-RIC)

Intervention Type: DEVICE

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Interventions

Remote ischemic conditioning (RIC)

RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 220mmHg and 5-min deflation.

Intervention Type: DEVICE

Sham remote ischemic conditioning (Sham-RIC)

The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 70 years old;
• mRS≤3;
• Meeting the DSM-IV diagnostic criteria for insomnia: in the past one month, the presence of any of the following symptoms: a. have difficulty falling asleep (sleep latency >30 minutes); b. have trouble in maintaining sleep; c. early awakening, accompanied by impaired daytime function, with symptoms occurring more than three times a week, lasting at least 2 weeks;
• Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria

• Chronic insomnia (PSQI≥8) or other sleep disorders was diagnosed 3 months before onset of stroke;
• Presence or past history of neuropsychiatric diseases such as epilepsy, brain tumors, neurodegenerative disorders, restless leg syndrome, periodic leg movement;
• Schizophrenia, significant anxiety and depression (HAMA≥14 points, HAMD≥17 points) with moderate to high suicide risk, etc;
• Serious infection, malignancy, and other serious medical conditions (acute heart, liver, renal failure and other diseases);
• Have taken any medications (antipsychotics, hypnotics, antidepressants, etc.) that interfere with sleep in the latest two weeks;
• Have work shift or jet lag experience 4 months before enrollment Infants, Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ji Xunming,MD,PhD

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xunming Ji

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuan Wu Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xunming Ji, MD, PhD

Role: CONTACT

jixm@ccmu.edu.cn

101-83199430

Jin Ma, MD

Role: CONTACT

2753297695@qq.com

13699188306

Other Identifiers

RIC-SI

Identifier Type: -

Identifier Source: org_study_id