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

Not Applicable

• Conditions: Epilepsy，Cognition
• Interventions: Device: transcutaneous vagus nerve stimulation; Device: sham transcutaneous vagus nerve stimulation; Other: Melatonin Tablets; Other: Lactasin Tablets

• Registration Number: NCT05256173
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-01
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcutaneous vagus nerve stimulation	transcutaneous vagus nerve stimulation	-
sham transcutaneous vagus nerve stimulation	sham transcutaneous vagus nerve stimulation	-
Melatonin Tablets	Melatonin Tablets	-
Lactasin Tablets	Lactasin Tablets	-

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	Week 4	The difference between the end of treatment score and the baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital,the Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China