Status:
UNKNOWN
Remote Ischemic Conditioning for the Treatment of Stroke-related Insomnia
Lead Sponsor:
Ji Xunming,MD,PhD
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-70 years
Phase:
NA
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 aft...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 13 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05289518
Start Date
April 1 2022
End Date
December 13 2023
Last Update
March 21 2022
Active Locations (1)
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1
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100053