Epilepsy，CognitionNCT05256173
Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
A study testing Melatonin Tablets, Lactasin Tablets and transcutaneous vagus nerve stimulation in people with Epilepsy，Cognition, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Epilepsy，Cognition
- What is being tested?
- Melatonin Tablets, Lactasin Tablets and transcutaneous vagus nerve stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital,the Air Force Medical University
Xi'an, Shaanxi
Lei Ma, associate professor, 18338963062, zhqshiguang@163.com
About this study
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
- Being tested
- Melatonin Tablets, Lactasin Tablets, transcutaneous vagus nerve stimulation, sham transcutaneous vagus nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin TabletsOther
Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.
Lactasin TabletsOther
The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.
transcutaneous vagus nerve stimulationDevice
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.
sham transcutaneous vagus nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Tablets | Experimental | Not described Receives: Other: Melatonin Tablets |
| Lactasin Tablets | Placebo comparator | Not described Receives: Other: Lactasin Tablets |
| transcutaneous vagus nerve stimulation | Experimental | Not described Receives: Device: transcutaneous vagus nerve stimulation |
| sham transcutaneous vagus nerve stimulation | Sham comparator | Not described Receives: Device: sham transcutaneous vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
The difference between the end of treatment score and the baseline
Measured: Week 4
Secondary outcomes (6)
Rey complex figure test
The difference between the end of treatment score and the baseline
Measured: Week 4
Rey auditory verbal learning test
The difference between the end of treatment score and the baseline
Measured: Week 4
Boston naming test
The difference between the end of treatment score and the baseline
Measured: Week 4
Quality of life questionnaire in epilepsy inventory
The difference between the end of treatment score and the baseline
Measured: Week 4
Wechsler Memory Scale
The difference between the end of treatment score and the baseline
Measured: Week 4
Pittsburgh sleep quality index
The difference between the end of treatment score and the baseline
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Feb 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy，CognitionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256173
- Sponsor's protocol ID
- KY20212171-F-1
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT05256173
- Acronym / sponsor ID
- KY20212171-F-1
- Conditions
- Epilepsy，Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Melatonin Tablets | Experimental | Other: Melatonin Tablets |
| Lactasin Tablets | Placebo comparator | Other: Lactasin Tablets |
| transcutaneous vagus nerve stimulation | Experimental | Device: transcutaneous vagus nerve stimulation |
| sham transcutaneous vagus nerve stimulation | Sham comparator | Device: sham transcutaneous vagus nerve stimulation |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin TabletsMelatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks. | Other | Melatonin Tablets |
| Lactasin TabletsThe placebo group was given at the beginning of bedtime at night for a total of 4 weeks. | Other | Lactasin Tablets |
| transcutaneous vagus nerve stimulationtranscutaneous 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 | transcutaneous vagus nerve stimulation |
| sham transcutaneous vagus nerve stimulationIn 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. | Device | sham transcutaneous vagus nerve stimulation |
Primary outcome
Montreal Cognitive Assessment
Time frame: Week 4
The difference between the end of treatment score and the baseline
6 secondary outcomes
Rey complex figure test
Time frame: Week 4
Rey auditory verbal learning test
Time frame: Week 4
Boston naming test
Time frame: Week 4
Quality of life questionnaire in epilepsy inventory
Time frame: Week 4
Wechsler Memory Scale
Time frame: Week 4
Pittsburgh sleep quality index
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin Tablets, Lactasin Tablets and transcutaneous vagus nerve stimulation in people with Epilepsy，Cognition, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Ma, associate professor (18338963062, zhqshiguang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.