Clinical trial NCT05289518: Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia
Official title: Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia：A Multicenter, Randomized, Double-blind, Sham-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: remote ischemic conditioning
acute ischemic stroke
insomnia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PSQI score(Pittsburgh sleep quality index)
timeFrame: From baseline to 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji
role: PRINCIPAL_INVESTIGATOR
References: