stroke
Conditions
Interventions
experimental group:The experimental group received conventional rehabilitation treatment, sleep hygiene and sleep health education combined with transauricular vagus nerve electrical stimulation. Rele
control group:The control group received conventional rehabilitation treatment, sleep hygiene and sleep health education combined with sham stimulation. Relevant assessments were performed before trea
Sponsors
The Affiliated Suzhou Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients meet the diagnosis of stroke-related insomnia; 2. Aged between 18 and 80 years old; 3. No other mental illness before stroke; 4. Stable heart rate, no history of arrhythmia such as sinus bradycardia and atrioventricular block; 5. Stable vital signs, no serious organic diseases or serious complications, such as severe heart failure, severe kidney failure, severe respiratory failure, cancer, etc.; 6. Voluntarily join this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients without insomnia after stroke; 2. Patients with unstable stroke condition who cannot be intervened; 3. Patients with mental illness or severe cognitive impairment who cannot express opinions and cannot cooperate with the examination; 4. Patients with contraindications to vagus nerve stimulation: including heart failure, sinus bradycardia, atrioventricular block, hypotension, and history of severe asthma; 5. Patients with skin allergies, injuries, inflammation, etc. at the test site who cannot be tested; 6. Patients who are pregnant or breastfeeding; 7. Alcoholism or psychotropic drug abuse and dependence; 8. Concurrent use of other treatments such as acupuncture, ear acupuncture, ear scraping, transcranial magnetic stimulation, etc. for the purpose of improving sleep disorders. 9. Patients and family members do not cooperate; All patients who meet any of the above items will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index, PSQI;Polysomnography, PSG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index, ISI;fatigue self-assessment scale, FFS;Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;Heart Rate Variability, HRV;Safety indicators; | — |
Countries
China
Contacts
Public ContactWei Tianqi
Department of Rehabilitation Medicine, The Affiliated Suzhou Hospital of Nanjing University Medical School
Outcome results
None listed