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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Tablets | Experimental |
| |
| Lactasin Tablets | Placebo Comparator |
| |
| transcutaneous vagus nerve stimulation | Experimental |
| |
| sham transcutaneous vagus nerve stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin Tablets | Other | Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment | The difference between the end of treatment score and the baseline | Week 4 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Ma, associate professor | Contact | 18338963062 | zhqshiguang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,the Air Force Medical University | Recruiting | Xi'an | Shaanxi | China |
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| Lactasin Tablets | Other | The placebo group was given at the beginning of bedtime at night for a total of 4 weeks. |
|
| transcutaneous vagus nerve stimulation | Device | 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. |
|
| sham transcutaneous vagus nerve stimulation | Device | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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