Circadian rhythm evaluation and polysomnographic sleep tracking in cluster headache attacks. - Clock, sleep and cluster headache (CIESTA)

eids Universitair Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•- Age >=18 and <70 years.
•- Diagnosed with either chronic or episodic cluster headache according to the
•International Classification of Headache Disorders - third edition (ICHD-3)
•o In case of episodic cluster headache: within 1 to 2 weeks from the start of
•the cluster episode, or in patients with a minimum of 4 expected weeks
•remaining in their cluster episode.
•- >=5 nocturnal cluster headache attacks per week and no more than two nights
•without any cluster headache attacks during the one-week baseline period.
•- On a stable regimen, or free of, cluster headache prophylactic therapy
•(including neuromodulation during the study period. Acute attack treatment with
•subcutaneous sumatriptan and/or 100% oxygen will be allowed and monitored.
•- Regular sleep habits

•- Inability to use a Dutch electronic headache diary
•- Other headaches if the patient cannot reliably distinguish them from attacks
•of cluster headache
•- Current use of prophylactic medication for other headaches
•- Diagnosis of a primary sleep disorder other than insomnia, including sleep
•apnoea syndrome
•- Known pituitary disorder
•- Pregnancy, lactation or trying to conceive (females)
•- Use of opiates
•- Estrogen containing oral contraceptive medication within the past 6 -weeks
•- Use of melatonin within past 6 weeks
•- Use of oral or parenteral glucocorticosteroids within past 3 months and/or
•use of oral, inhaled or parenteral glucocorticosteroids during the study period
•- Use of medication that effects melatonin production, such as beta blockers.

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