Back to resultsClinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
Primary Purpose
Epilepsy，Cognition
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Melatonin Tablets
Lactasin Tablets
transcutaneous vagus nerve stimulation
sham transcutaneous vagus nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy，Cognition
Eligibility Criteria
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).
Sites / Locations
- The First Affiliated Hospital,the Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Sham Comparator
Arm Label
Melatonin Tablets
Lactasin Tablets
transcutaneous vagus nerve stimulation
sham transcutaneous vagus nerve stimulation
Arm Description
Outcomes
Primary Outcome Measures
Montreal Cognitive Assessment
The difference between the end of treatment score and the baseline
Secondary Outcome Measures
Rey complex figure test
The difference between the end of treatment score and the baseline
Rey auditory verbal learning test
The difference between the end of treatment score and the baseline
Boston naming test
The difference between the end of treatment score and the baseline
Quality of life questionnaire in epilepsy inventory
The difference between the end of treatment score and the baseline
Wechsler Memory Scale
The difference between the end of treatment score and the baseline
Pittsburgh sleep quality index
The difference between the end of treatment score and the baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05256173
Brief Title
Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
Official Title
Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy，Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin Tablets
Arm Type
Experimental
Arm Title
Lactasin Tablets
Arm Type
Placebo Comparator
Arm Title
transcutaneous vagus nerve stimulation
Arm Type
Experimental
Arm Title
sham transcutaneous vagus nerve stimulation
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Melatonin Tablets
Intervention Description
Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.
Intervention Type
Other
Intervention Name(s)
Lactasin Tablets
Intervention Description
The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.
Intervention Type
Device
Intervention Name(s)
transcutaneous vagus nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham transcutaneous vagus nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Rey complex figure test
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Title
Rey auditory verbal learning test
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Title
Boston naming test
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Title
Quality of life questionnaire in epilepsy inventory
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Title
Wechsler Memory Scale
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
Title
Pittsburgh sleep quality index
Description
The difference between the end of treatment score and the baseline
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Ma, associate professor
Phone
18338963062
Email
zhqshiguang@163.com
Facility Information:
Facility Name
The First Affiliated Hospital,the Air Force Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Ma, associate professor
Phone
18338963062
Email
zhqshiguang@163.com
12. IPD Sharing Statement
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Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
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