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Recruiting NCT06545643

Sleep-Sensitive Seizure Risk Assessment With Wearable EEGs

No phase Interventional Epilepsy Intractable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dreem headband.
Who it may be relevant to
Registry conditions: Epilepsy Intractable. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Personalized Risk Assessment of Seizures Sensitive to Poor Sleep: a Longitudinal Study Using Wearable Electroencephalography Devices

Overview

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.

Detailed description

The first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. The investigators will conduct longitudinal EEG assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time.

The second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the Sleep-Sensitive Epilepsy Risk Index (SERI). This index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.

Interventions

  • Device Dreem headband
    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.

Primary outcome measures

  • Total sleep time (sleep macrostructure) [Time frame: 21 days]
  • Spike rates per hour (epilepsy marker) [Time frame: 21 days]
  • Seizure frequency per night (epilepsy marker) [Time frame: 21 days]
Secondary outcome measures (10)
  • Sleep latency (sleep macrostructure) [Time frame: 21 days]
  • Wake after sleep onset (sleep macrostructure) [Time frame: 21 days]
  • Sleep efficiency (sleep macrostructure) [Time frame: 21 days]
  • Sleep stage distribution (sleep macrostructure) [Time frame: 21 days]
  • Sleep spindle events (sleep microstructure) [Time frame: 21 days]
  • Sleep slow wave events (sleep microstructure) [Time frame: 21 days]
  • Performance the SERI model, as measured by the area under the receiver operating characteristic curve [Time frame: Up to 2 years after study commencement]
  • Sensitivity of the SERI model [Time frame: Up to 2 years after study commencement]
  • Specificity of the SERI model [Time frame: Up to 2 years after study commencement]
  • Performance the SERI model, as measured by F1-score [Time frame: Up to 2 years after study commencement]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Apnea-hypopnea index of > 10/h

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Duke University Health System — Durham

Identifiers

NCT: NCT06545643 · Pro00115560

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗