Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFebruary 25, 2022
February 1, 2022
9 months
February 16, 2022
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Montreal Cognitive Assessment
The difference between the end of treatment score and the baseline
Week 4
Secondary Outcomes (6)
Rey complex figure test
Week 4
Rey auditory verbal learning test
Week 4
Boston naming test
Week 4
Quality of life questionnaire in epilepsy inventory
Week 4
Wechsler Memory Scale
Week 4
- +1 more secondary outcomes
Study Arms (4)
Melatonin Tablets
EXPERIMENTALLactasin Tablets
PLACEBO COMPARATORtranscutaneous vagus nerve stimulation
EXPERIMENTALsham transcutaneous vagus nerve stimulation
SHAM COMPARATORInterventions
Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.
The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.
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.
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.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
The First Affiliated Hospital,the Air Force Medical University
Xi'an, Shaanxi, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
February 1, 2022
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
February 25, 2022
Record last verified: 2022-02