Circadian rhythm evaluation and polysomnographic sleep tracking in cluster headache attacks.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

- 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)
criteria.
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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>The risk of the occurrence of a cluster headache attack depending on sleep<br /><br>stage, melatonin level, cortisol level and clock time (hazard ratio).<br /><br><br /><br>Sleep stage is defined as REM, N1, N2, N3 or wake. Melatonin and cortisol<br /><br>values will be defined as the relative increase or decrease compared to an<br /><br>individuals average value during the study period.<br /><br><br /><br>Part 2:<br /><br>Difference in sleep stage distribution (percentage REM and non-REM), the<br /><br>average melatonin zenith (peak) and the average cortisol nadir (through)<br /><br>between ECH patients in bout versus ECH patients out of bout.</p><br>

Secondary Outcome Measures