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Headband tracks sleep to warn of seizure danger

NCT ID NCT06545643

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses a comfortable headband (Dreem) to monitor brain activity and sleep patterns in 35 adults with hard-to-control epilepsy. Participants wear the device at home for several nights to see how poor sleep affects their seizures. The goal is to learn which patients are most at risk after bad sleep, so doctors can tailor treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dreem headband (wearable EEG device)
What this could lead to
If successful, this could help doctors identify which people with epilepsy are most sensitive to poor sleep, leading to personalized treatment plans.
What could go wrong
This is a small, early observational study (35 people) that only measures sleep and seizures—it does not test a treatment. Results may not apply to everyone with epilepsy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy intractable

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

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