Epilepsy
Conditions
Keywords
epilepsy, sleep, antiepileptic drugs
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.
Interventions
None listed
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Patients Treated With Clobazam | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 13 Participants | — |
| Age, Continuous | 41 years STANDARD_DEVIATION 11.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 1 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam
The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose
Time frame: 1 week after reaching effective clobazam dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Treated With Clobazam | Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam | Baseline Phase | 493.2 minutes | Standard Deviation 457.9 |
| Patients Treated With Clobazam | Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam | Treatment Phase | 457.9 minutes | Standard Deviation 23.9 |
Secondary
Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam
The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose
Time frame: 1 week after reaching effective clobazam dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Treated With Clobazam | Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam | Baseline Phase | 50.2 count of awakenings | Standard Deviation 6.9 |
| Patients Treated With Clobazam | Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam | Treatment Phase | 37.3 count of awakenings | Standard Deviation 3.5 |