clusterheadache Trigeminal Autonomic Cephalalgias (TAC)
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 and =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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The risk of the occurrence of a cluster headache attack depending on sleep stage, melatonin level, cortisol level and clock time (hazard ratio). Sleep stage is defined as REM, N1, N2, N3 or wake. Melatonin and cortisol values will be defined as the relative increase or decrease compared to an individuals average value during the study period. Part 2: Difference in sleep stage distribution (percentage REM and non-REM), the average melatonin zenith (peak) and the average cortisol nadir (through) between ECH patients in bout versus ECH patients out of bout. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters serve an exploratory character and will be addressed if possible. Part 1 Sleep: - The sleep stage (stage 1/N1, stage 2/N2, stage 3/N3 and REM) directly prior to attack onset. Results will be reported as a percentage of attacks per sleep stage. - The time between transition in sleep stage and attack onset, to determine whether transition between REM sleep and non-REM sleep precipitates an attack - The time at which the first nocturnal attack occurs Circadian rhythm markers: - The average melatonin level at attack onset - The average cortisol level at attack onset - The average melatonin zenith and nadir - The average cortisol zenith and nadir - Average core temperature at attack onset - Average proximal skin temperature at attack onset - Time from core body temperature zenith and nadir to attack onset - Time from skin temperature zenith and nadir to attack onset - Sympathicovagal balance (heart rate variability) at attack onset Part 2 To compare several characteristics of sleep and the biological clock in patients during an active cluster period versus remission, i.e.: - The average sleep latency - The average total sleep time - The average sleep efficiency - The percentage of REM sleep and non-REM sleep of total sleeping time - The average REM latency - The average REM density - The REM fragmentation - The gross motor activity as a measure for hypoarousability during REM sleep - Average core body temperature - Average proximal skin temperature | — |
Countries
Netherlands
Outcome results
None listed