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Completed

NCT Number: NCT02911025

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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