An observational study in Migraine and Cluster Headache, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by University Hospital, Ghent · Observational
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 19 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Migraine or cluster headache patients
Exclusion Criteria:
Wearable wrist sensor + headache application on smartphone
Procedure: Wearable sensor detection
Wearable wrist sensor + headache application on smartphone
Procedure: Wearable sensor detection
Empatica E4 wearable wrist sensor
Galvanic Skin Response changes
Changes in GSR through the different phases of the headache attacks
Time frame: 21 days
Activity ratio
Activity ratio measurement through accelerometer data
Time frame: 21 days
Skin temperature
Skin temperature measurement through builtin thermometer
Time frame: 21 days
Prevalence of premonitory symptoms
Time frame: 21 days
Prevalence of cranial autonomic symptoms
Time frame: 21 days
Prevalence of postdromal symptoms
Time frame: 21 days
MSQv2.1 questionnaire
In migraine patients
Time frame: 21 days
MIDAS questionnaire
In migraine patients
Time frame: 21 days
SF20
In migraine and cluster headache patients
Time frame: 21 days
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent