Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia (RIC-SI)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Remote ischemic conditioning (RIC); Device: Sham remote ischemic conditioning (Sham-RIC)

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 Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xunming Ji, MD, PhD; Phone Number: 101-83199430; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Jin Ma, MD; Phone Number: 13699188306; Email: 2753297695@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuan Wu Hospital，Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Subjects in the intervention group will recieve remote ischemic conditioning (RIC) treatment twice a day for 3 months.	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_COMPARATOR: Sham control group; Subject in the sham control group will recieve sham remote ischemic conditioning (Sham-RIC) treatment twice a day for 3 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ji Xunming,MD,PhD

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): December 13, 2023
• Study Completion (ANTICIPATED): December 13, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (ACTUAL): March 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: remote ischemic conditioning; insomnia; acute ischemic stroke
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Stroke; Ischemic Stroke; Ischemia; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: RIC-SI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No