Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

Mass General Brigham

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Other

Identifiers

NCT02911025

2014P001657

Details and patient eligibility

About

The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 1 patient group

Patients Treated With Clobazam

Description:

Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.