Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

Epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. Sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. Studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. Wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. The Dreem headband, an EEG-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. This technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. By elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

At least 2 seizures per week based on clinical notes

Patients where medications will stay stable over the study period

40% of both spikes and spindles are identifiable on the dreem headband based on the screening night

Disqualifiers

Cognitive impairment

Psychiatric comorbidities which may influence sleep

No bedpartner/caregiver to observe seizures

Low agreement (below 60%) between Dreem's sleep scoring and manual scoring will be excluded from the study

Trial design

Design model

Single group

Treatments tested in this trial

  • Dreem headband

    Device

    The Dreem headband is an EEG-based wearable tool that can be used to reliably assess the relationship between sleep and epilepsy over extended observation periods.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Dreem headbandExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total sleep time (sleep macrostructure)

Total sleep time as measured by the Dreem headband

Time frame
21 days
2

Spike rates per hour (epilepsy marker)

Spikes will be detected by the Dreem headband

Time frame
21 days
3

Seizure frequency per night (epilepsy marker)

Seizures will be detected by the Dreem headband

Time frame
21 days

Secondary outcomes

1

Sleep latency (sleep macrostructure)

Sleep latency as measured by the Dreem headband

Time frame
21 days
2

Wake after sleep onset (sleep macrostructure)

Wake after sleep onset as measured by the Dreem headband

Time frame
21 days
3

Sleep efficiency (sleep macrostructure)

Sleep efficiency as measured by the Dreem headband

Time frame
21 days
4

Sleep stage distribution (sleep macrostructure)

Sleep stage distribution as measured by the Dreem headband

Time frame
21 days

Other outcomes

Sponsors and contacts

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