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

Completed

• Conditions: Epilepsy

• Registration Number: NCT02911025
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2020-03-13
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Results First Posted: 2021-02-08
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam	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 Outcome Measures

Name	Time	Method
Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam	1 week after reaching effective clobazam dose	The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Faulkner Hospital; 🇺🇸 Jamaica Plain, Massachusetts, United States