Status:
UNKNOWN
Stimulation of Sleep in Patients With Epilepsy
Lead Sponsor:
University Children's Hospital, Zurich
Collaborating Sponsors:
ETH Zurich
University of Zurich
Conditions:
Epilepsy
Eligibility:
All Genders
4-30 years
Phase:
NA
Brief Summary
Sleep slow waves (SSW) and the pathophysiological mechanisms of spike generation in patients with epilepsy are tightly linked. SSW are cortically generated oscillations (\~1 Hz) alternating between a ...
Detailed Description
The investigators aim to evaluate the effect of closed-loop auditory stimulation during sleep in healthy children, adolescents and adults, as well children, adolescents and adults with epilepsy. Durin...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Participants of any gender
- Children, adolescents and young adults (4-30 years old)
- Right-handed
- Written informed consent by the participant or, if applicable, by their legal guardian after receiving information about the study For healthy participants:
- Good general health status
- For patients with epilepsy:
- Diagnosed with epilepsy
- Wake or sleep EEG within the last 12 months showing epileptic discharges.
- Attending a regular school.
- Exclusion criteria
- Irregular sleep-wake rhythm
- Shift work
- Daytime sleep
- Excessive sweating
- Obesity
- Sleep, psychiatric, neurological or physical disorders or illnesses other than epilepsy
- Hearing disorder
- Travelling across 2 or more time zones within the last month
- Pregnancy
- Skin allergy or very sensitive skin
- Drug and medication use or abuse other than for the treatment of epilepsy
- Daily nicotine use
- High caffeine consumption, including coffee, black and green tea, mate, cola, energy drinks, and iced tea
- \<16 years: \>1 servings/day = \>80 mg caffeine
- \>=16 years: \>2 servings/day = \>160 mg caffeine
- Alcohol consumption
- \<16 years: any alcohol
- 16-17 years: \>3-4 standard servings per week
- \>=18 years: \>1 standard serving per day (\>14 mg)
- Inability to follow the procedures of the study For patients with epilepsy:
- Epilepsy syndromes with a high risk of seizure occurrence during the study night
- Generalized motor and/or focal motor seizure frequency \>1/week
- Generalized motor and/or focal motor seizure within 24h before the study night
- History of convulsive status epilepticus
- History of seizures provoked by sleep deprivation
- Treatment with corticosteroids, immunosuppressants or vagus nerve stimulation
Exclusion
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04716673
Start Date
July 29 2020
End Date
December 1 2025
Last Update
January 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Children's Hospital Zurich
Zurich, Switzerland, 8032