Efficacy and safety of vagus nerve stimulation on sleep disorders in patients with stroke

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: experimental group:The experimental group received conventional rehabilitation treatment, sleep hygiene and sleep health education combined with transauricular vagus nerve electrical stimulation. Relevant assessments were performed before treatment and immediately after the 2‐week and 4‐week treatment courses, and the scale was followed up 4 weeks after the treatment course. ;control group:The control group received conventional rehabilitation treatment, sleep hygiene and sleep health education combined with sham stimulation. Relevant assessments were performed before treatment, 2 weeks after treatment, and 4 weeks after treatment. Follow‐up was performed with a scale 4 weeks after the treatment.; CONDITION: stroke PRIMARY OUTCOME: Pittsburgh Sleep Quality Index, PSQI;Polysomnography, PSG; SECONDARY OUTCOME: Insomnia Severity Index, ISI;fatigue self‐assessment scale, FFS;Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;Heart Rate Variability, HRV;Safety indicators; 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.
Epistemonikos ID: ecb119dfb37bdeb161a098f172c77c077b68ad75
First added on: Jan 24, 2026