Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam
Study Overview
Brief Summary
The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.
Detailed Description
Many studies show that patients with epilepsy frequently have disrupted sleep, as well as a high level of daytime sleepiness. This may be due to a sleep disorder, nighttime seizures that lead to disrupted sleep, and other abnormalities. Sleep complaints are widely reported among patients with various epilepsy syndromes.
Anti-seizure treatments may affect sleep. Effects vary by type of medication and other health issues. Generally, with improvement of seizure control, the sleep cycle improves and becomes more regular. However, some anti-seizure medications have been associated with insomnia. There have been studies that looked at sleep in relation to some anti-seizure medications. However, there are no currently available published reports on the effect of Clobazam (Onfi) on sleep.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults aged 18 years or older
- •diagnosis of epilepsy who are being considered for treatment with Clobazam
Exclusion Criteria
- •known untreated moderate or severe sleep apnea
- •major circadian rhythm disorders
Outcomes
Primary Outcomes
Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam
Time Frame: 1 week after reaching effective clobazam dose
The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose
Secondary Outcomes
- Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam(1 week after reaching effective clobazam dose)
Investigators
Pavlova, Milena,M.D.
Assistant Professor, Harvard Medical School
Brigham and Women's Hospital