Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT04949204
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPIMAC
Brief Summary:
This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.
Detailed Description:
Migraine and cluster headache are among the most disabling headache conditions in humans. Both conditions have different phases such as the prodromal/premonitory phase, the aura phase, the headache phase and the postdromal phase. This pilot study examines the potential of wearable sensors combined with machine learning algorithms to investigate the biological changes over time in both conditions. Behaviour such as movement, sleep and activity will be monitored. Stress levels will be estimated through the wearable data combined with input from the patients. Participants will use a wearable device around the wrist and self-developed headache application for 21 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: