Epilepsy comorbidities sleep disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for epilepsy of the International League against Epilepsy (ILAE) in 2017, and meet the diagnostic criteria of the International Classification of Sleep Disorders, third edition; 2. Age 14-60 years old, education level can complete the relevant examination; 3. Chinese handedness was rated as right-handedness; 4. no other neurological diseases, no family history of genetic disease; 5. Based on 1 month before the application of pirampanel, the frequency of seizures could not be controlled, and the frequency of seizures was two or more times; 6. Treatment with other fixed antiepileptic drugs plus pirampanil alone lasted for three months or more; 7. The subject or guardian voluntarily agrees to participate in this study and can provide complete case data.
Exclusion criteria
Exclusion criteria: 1. Progressive central nervous system diseases, serious heart, lung, liver, kidney diseases; 2. Taking immunosuppressants, central nervous system inhibitors, sleeping pills and other drugs that may affect sleep; Individuals with unstable recurrent affective disorder who are using antipsychotics or have a mental illness or a suicide attempt within 1 year prior to enrollment; 3. Women who are pregnant, breastfeeding and do not take contraceptive measures; 4. People with lactose intolerance, lactose deficiency or rare genetic diseases such as glucose-lactose absorption disorder; 5. Allergic to the drug or ingredient; 6. Patients with severe sleep disorders;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| polysomnography (PSG);Pittsburgh Sleep Quality Index Scale;Insomnia Severity Index Scale;Epworth Sleepiness Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;Difference in seizure frequency at 1, 2, 3 months post-medication administration from pre-treatment baseline data;Drug side effects; | — |
Countries
China
Contacts
Affiliated Hospital of Zunyi Medical University