Auditory stimulation to improve sleep in epilepsy patients
Investigating the Effect of Closed-loop Auditory Stimulation on Sleep and Behavior in Patients With Epilepsy and Healthy Controls: a Developmental Study
NA · University Children's Hospital, Zurich · NCT04716673
This study is testing whether using sound while you sleep can help improve sleep quality for people with epilepsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 30 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich (other) |
| Locations | 1 site (Zurich) |
| Trial ID | NCT04716673 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of closed-loop auditory stimulation during sleep on patients with epilepsy and healthy controls. By applying brief auditory stimuli at specific moments during sleep, the researchers aim to enhance sleep slow waves and assess their impact on sleep EEG characteristics and behavior. Participants will undergo sleep recordings and assessments of their usual sleeping behavior to evaluate the effectiveness of this non-invasive intervention. The goal is to understand how targeted auditory stimulation can influence sleep-dependent neuroplasticity in individuals with epilepsy.
Who should consider this trial
Good fit: Ideal candidates include children, adolescents, and young adults aged 4-30 diagnosed with epilepsy who exhibit epileptic discharges in their sleep EEG.
Not a fit: Patients with irregular sleep-wake rhythms, other significant sleep or psychiatric disorders, or those on medications affecting sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved sleep quality and reduced epileptic discharges in patients with epilepsy.
How similar studies have performed: While the approach of using auditory stimulation during sleep is innovative, similar studies have shown promise in enhancing sleep quality and brain activity.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich
- University Children's Hospital Zurich — Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Reto Huber, Prof. Dr. — University Children's Hospital, Zurich
- Study coordinator: Sven Leach, M. Sc.
- Email: sven.leach@kispi.uzh.ch
- Phone: +41 44 266 3217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, epilepsy, sleep, closed-loop auditory stimulation, epileptic discharges, spikes