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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transcranial Stimulation During Sleep to Improve Cognition in Epilepsy

NCT02268591

Epilepsy

WITHDRAWN NA

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

NCT06524479

Refractory Epilepsy Sleep

RECRUITING NA

A Study of Meditation as a Treatment for Epilepsy

NCT00370929

Epilepsy

COMPLETED NA

Transcranial Electrical Stimulation Targeting the Cerebellum for the Treatment of Refractory Temporal Lobe Epilepsy

NCT06558890

Transcranial Electrical Stimulation Temporal Lobe Epilepsy Magnetic Resonance Imaging +1 more

RECRUITING NA

Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness

NCT06851156

Disorders of Consciousness Severe Brain Injury Unresponsive Wakefulness Syndrome +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy，Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Melatonin Tablets

Group Type EXPERIMENTAL

Melatonin Tablets

Intervention Type OTHER

Melatonin Tablets was given 3 tablets (6.21mg) daily at the beginning of bedtime at night for a total of 4 weeks.

Lactasin Tablets

Group Type PLACEBO_COMPARATOR

Lactasin Tablets

Intervention Type OTHER

The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.

transcutaneous vagus nerve stimulation

Group Type EXPERIMENTAL

transcutaneous vagus nerve stimulation

Intervention Type DEVICE

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 stimulation

Group Type SHAM_COMPARATOR

sham transcutaneous vagus nerve stimulation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin Tablets

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

Lactasin Tablets

The placebo group was given at the beginning of bedtime at night for a total of 4 weeks.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

7 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No