Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

Not Applicable

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Remote ischemic conditioning (RIC); Device: Sham remote ischemic conditioning (Sham-RIC)

• Registration Number: NCT05289518
• Lead Sponsor: Ji Xunming,MD,PhD

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.

Study Timeline

• Study First Submitted: 2022-02-07
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-21
• Last Update Posted: 2022-03-21
• Study Start: 2022-04-01
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PSQI score(Pittsburgh sleep quality index)	From baseline to 3months	PSQI score of baseline and treatment after 1, 2, 3months . The the minimum value is 0, and the maximum value is 21.Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Xuan Wu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China