NCT05289518

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

February 7, 2022

Last Update Submit

March 18, 2022

Conditions

Acute Ischemic Stroke

Keywords

remote ischemic conditioningacute ischemic strokeinsomnia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Remote ischemic conditioning (RIC)

Sham control group

SHAM COMPARATOR

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)

Interventions

Remote ischemic conditioning (RIC)DEVICE

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 group
Sham remote ischemic conditioning (Sham-RIC)DEVICE

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.

Sham control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Ischemic StrokeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Xunming Ji

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD, PhD

CONTACT

101-83199430jixm@ccmu.edu.cn

Jin Ma, MD

CONTACT

136991883062753297695@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 21, 2022

Study Start

April 1, 2022

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

CN(1)