An interventional study of Wearable sensor and smartphone application 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 2024-02-06.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Diagnostic
This study collects data from migraine and cluster headache patients during a three-month study. Contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.
Migraine and cluster headache are brain disorders with disabling headache attacks and assoicated symptoms. Attacks have multiple phases such as the premonitory phase, aura phase, headache phase and postdromal phase. During those phases, symptoms of homeostatic disturbance or sensory alterations may occur.
The goal of the study is to observe activity, stress and sleep parameters in relation to registered headache attacks.
Participation in the mBrain-21 study will last maximum 90 days. Participants are patients with migraine or cluster heacache recruited within the headache clinic of Ghent University Hospital. Physiological variables such as heart rate, movement and galvanic skin resonse will be measured by the Empatica E4 wrist sensor. Patient-specific experiences during headache attacks and activities of daily life will be registered with a custom-made headache smartphone applications. Contextual data (e.g. smartphone usage or location) can be autonomously collected through smartphone applications.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 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.
Exclusion Criteria:
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Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.
Device: Wearable sensor and smartphone application
Empatica E4 wearable sensor and custom-made headache smartphone application
Accuracy (F1-scores) machine learning algorithms
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
Time frame: After 90 days
Demographics
Demographic characteristics of participants
Time frame: At the beginning of the study
Headache phenotype characteristics
Headache phenotype characteristics
Time frame: At the beginning of the study
Migraine Specific Questionnaire v2.1
Migraine Specific Questionnaire v2.1
Time frame: After 90 days
MIDAS Migraine Disability Assessment
MIDAS Migraine Disability Assessment
Time frame: After 90 days
MOS Short-Form General Health Survey (SF-20)
MOS Short-Form General Health Survey (SF-20)
Time frame: After 90 days
Pittsburgh Sleep Quality index
Pittsburgh Sleep Quality index
Time frame: After 90 days
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Time frame: After 90 days
Perceived Stress Scale (PSS-10)
Perceived Stress Scale (PSS-10)
Time frame: After 90 days
Connor Davidson Resilience Scale (CD-RISC 25)
Connor Davidson Resilience Scale (CD-RISC 25)
Time frame: After 90 days
Penn State Worry Questionnaire (PSWQ)
Penn State Worry Questionnaire (PSWQ)
Time frame: After 90 days
Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
Time frame: After 90 days
Ruminative Response Scale (RRS)
Ruminative Response Scale (RRS)
Time frame: After 90 days
Basic Needs Scale
Basic Needs Scale
Time frame: After 90 days
Emotion Regulation Scale
Emotion Regulation Scale
Time frame: After 90 days
Neuroticism (subscale from BFI)
Neuroticism (subscale from BFI)
Time frame: After 90 days
Feedback from participants
Feedback from participants on compliance, adherence, usability and user experience of study infrastructure
Time frame: After 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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