Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
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|ClinicalTrials.gov Identifier: NCT02911025|
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2016
Last Update Posted : October 21, 2016
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||September 2017|
Patients Treated With Clobazam
Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
- Change in sleep (total sleep time, wake after sleep onset) in patients with epilepsy treated with clobazam [ Time Frame: 1 week after reaching effective clobazam dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911025
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Brigham and Women's Faulkner Hospital|
|Jamaica Plain, Massachusetts, United States, 02130|
|Principal Investigator:||Milena Pavlova, MD||Brigham and Women's Hospital|