NCT05256173

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy，Cognition

Interventions

Type	Name	Description
OTHER	Melatonin Tablets	Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.
OTHER	Lactasin Tablets	The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.
DEVICE	transcutaneous vagus nerve stimulation	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.
DEVICE	sham transcutaneous vagus nerve stimulation	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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2022-02-25
• Last updated: 2022-02-25

Locations

1 site across 1 country: China