Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03206502
Eligibility Criteria:
Inclusion Criteria:
* Participants must be between the ages of 1-99
* Anyone (healthy or not) can participate
* Adult participant must either be able to give consent or must have an acceptable surrogate capable of giving consent on their behalf.
* Participants under age 18 must have an adult guardian give informed consent, and if capable, the patient must give informed assent.
* Participants with GTCS must have a functioning smartphone (iOS or Android) that can be paired with the Embrace over a Bluetooth Low Energy connection and agree that it can be kept on or near their person.
* Participants with GTCS (or their surrogate) must be able to identify one or more "designated frequent caregivers," who has a functioning phone, agrees to keep it regularly charged, agrees to receive alerts, and agrees to respond to alerts promptly to the best of their ability.
* Participants must be fluent in the language of the consent forms (Currently limited to English but Spanish and other languages are planned).
* Participants must reside in the United States.
Exclusion Criteria:
* Participants must not have broken or injured skin at the wrist or leg location where Embrace is worn, and they must be able to tolerate wearing Embrace snugly for long periods of time. Thus, they should not have allergies to the material composition of the Embrace watch, or discomfort wearing a wristwatch or leg-band device.
* Participants should not be homeless.
* Participants should not have active dependence on substances that are not currently prescribed by their doctor (e.g. alcohol, pain medications, illegal drugs) or be taking substances that they are not willing to disclose as a study participant.
* Participants must not be pregnant or planning to become pregnant within six months at the time of screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
99 Years
Study:
NCT03206502
Study Brief:
Protocol Section:
NCT03206502