Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy

Study Overview
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Brief Summary
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Epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. At present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. Recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. The purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.

Official Title
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Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy

Conditions
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Epilepsy，Cognition

Intervention / Treatment
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* Other: Melatonin Tablets
* Other: Lactasin Tablets
* Device: transcutaneous vagus nerve stimulation
* Device: sham transcutaneous vagus nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. In accordance with the diagnostic criteria of epilepsy; 2. History of epilepsy ≥ 1 year; 3. Epilepsy with cognitive impairment; 4. Age 7-65 years old; 5. There was no change in the type and dose of antiepileptic drugs during the experiment; 6. Patients and their families were aware of this study and signed an informed consent form. Exclusion Criteria: 1. Status epilepticus; 2. Complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs; 3. Non-epileptic seizures such as syncope and hysteria; 4. Women during lactation or pregnancy; 5. Combined use of sleeping and sedative drugs; 6. There are contraindications of melatonin and percutaneous vagal nerve stimulation (tVNS).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin Tablets<br> | Other: Melatonin Tablets<br>* Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.<br>|
| Placebo Comparator: Lactasin Tablets<br> | Other: Lactasin Tablets<br>* The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.<br>|
| Experimental: transcutaneous vagus nerve stimulation<br> | Device: transcutaneous vagus nerve stimulation<br>* transcutaneous vagus nerve stimulation treatment, frequency 10Hz, stimulation site is the anterior wall of the left external auditory canal (tragus), used twice a day, each treatment for 30 minutes, a total of 4 weeks.<br>|
| Sham Comparator: sham transcutaneous vagus nerve stimulation<br> | Device: sham transcutaneous vagus nerve stimulation<br>* In the sham stimulation group, the stimulation site was the left earlobe with a frequency of 10Hz, which was used twice a day for 30 minutes for a total of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | The difference between the end of treatment score and the baseline | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rey complex figure test | The difference between the end of treatment score and the baseline | Week 4 | 
| Rey auditory verbal learning test | The difference between the end of treatment score and the baseline | Week 4 | 
| Boston naming test | The difference between the end of treatment score and the baseline | Week 4 | 
| Quality of life questionnaire in epilepsy inventory | The difference between the end of treatment score and the baseline | Week 4 | 
| Wechsler Memory Scale | The difference between the end of treatment score and the baseline | Week 4 | 
| Pittsburgh sleep quality index | The difference between the end of treatment score and the baseline | Week 4 |