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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Epilepsy，Cognition

Treatments: Device: transcutaneous vagus nerve stimulation; Other: Lactasin Tablets; Other: Melatonin Tablets; Device: sham transcutaneous vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05256173

KY20212171-F-1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 7 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

Melatonin Tablets

Experimental group

Treatment:

Other: Melatonin Tablets

Lactasin Tablets

Placebo Comparator group

Treatment:

Other: Lactasin Tablets

transcutaneous vagus nerve stimulation

Experimental group

Treatment:

Device: transcutaneous vagus nerve stimulation

sham transcutaneous vagus nerve stimulation

Sham Comparator group

Treatment:

Device: sham transcutaneous vagus nerve stimulation