Implementing Artificial-intelligence Wristbands to Help in Recording Seizures
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Embrace
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- At least one seizure per month in the 3-month period before entering the study
Exclusion Criteria:
- Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet <80,000/μL, neutrophil <1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease (except anxiety).
Sites / Locations
- Taichung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMBRACE USERS
Arm Description
Embrace wristband users
Outcomes
Primary Outcome Measures
Satisfaction score of seizure wristband
Scores 1(least satisfied) to 10 (most satisfied)
Secondary Outcome Measures
Full Information
NCT ID
NCT04505852
First Posted
August 5, 2020
Last Updated
April 26, 2022
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04505852
Brief Title
Implementing Artificial-intelligence Wristbands to Help in Recording Seizures
Official Title
Implementing Artificial-intelligence Wristbands to Help in Recording Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace
Detailed Description
Currently, seizure tracking relies on subjective patient and family recall. In several studies patients report only approximately half of their seizures, and even less during sleep.
Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or autonomic nervous system dysfunction.
Wristband sensors help caregivers assist patients during seizures and may reduce risks for complications such as injuries and SUDEP.
Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.
The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of 93.1%. The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace.
Methods:
When the smart wristband detects the seizure, the mobile phone sends a text message to the companion and the nurse, the latter will see or get in touch with the companion and keep a record.
In-patients receiving video-electroencephalography (VEEG) exam use Embrace during the VEEG recording which usually takes 3-5 days.
Out-patients use Embrace for 8 weeks. The investigators will enroll 30-50 patients, half in-patients and half out-patients.
The benefits are evaluated in terms of satisfaction. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMBRACE USERS
Arm Type
Experimental
Arm Description
Embrace wristband users
Intervention Type
Device
Intervention Name(s)
Embrace
Intervention Description
Patients wear Embrace2 to help in seizure reporting and patient care.
Primary Outcome Measure Information:
Title
Satisfaction score of seizure wristband
Description
Scores 1(least satisfied) to 10 (most satisfied)
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least one seizure per month in the 3-month period before entering the study
Exclusion Criteria:
Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet <80,000/μL, neutrophil <1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease (except anxiety).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PEIYUAN F. HSIEH, MD
Phone
886-4-23592525
Ext
3021
Email
pfhsieh@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PEIYUAN F. HSIEH, MD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementing Artificial-intelligence Wristbands to Help in Recording Seizures
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