Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

Acute Ischemic Stroke Clinical Trial

— RIC-SI  

Official title:

Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia：A Multicenter, Randomized, Double-blind, Sham-controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289518
• Other study ID #: RIC-SI
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: March 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD, PhD
• Phone: 101-83199430
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Stroke
• Sleep Initiation and Maintenance Disorders
• Stroke

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Xuan Wu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSQI score(Pittsburgh sleep quality index)	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.	From baseline to 3months