NCT05289518

Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Ji Xunming,MD,PhD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2022-03-21
• Last updated: 2022-03-21

Locations

1 site across 1 country: China