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

Primary Purpose

Acute Ischemic Stroke

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote ischemic conditioning (RIC)

Sham remote ischemic conditioning (Sham-RIC)

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring remote ischemic conditioning, acute ischemic stroke, insomnia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xuan Wu Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Sham control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05289518

First Posted

February 7, 2022

Last Updated

March 18, 2022

Sponsor

Ji Xunming,MD,PhD

1. Study Identification

Unique Protocol Identification Number

NCT05289518

Brief Title

Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

Acronym

RIC-SI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

December 13, 2023 (Anticipated)

Study Completion Date

December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ji Xunming,MD,PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

remote ischemic conditioning, acute ischemic stroke, insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

Sham control group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Remote ischemic conditioning (RIC)

Intervention Description

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

Intervention Name(s)

Sham remote ischemic conditioning (Sham-RIC)

Intervention Description

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.

Primary Outcome Measure Information:

Title

PSQI score(Pittsburgh sleep quality index)

Description

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.

Time Frame

From baseline to 3months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xunming Ji, MD, PhD

Phone

101-83199430

jixm@ccmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Ma, MD

Phone

13699188306

2753297695@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xunming Ji

Organizational Affiliation

Xuanwu Hospital, Beijing

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuan Wu Hospital,Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

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Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia

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