Part 1To determine if certain sleep stages (wake, REM, N1, N2, N3), and relatively high or low melatonin and cortisol levels, respectively, are associated with an increased or decreased instantaneous risk of cluster headache attacks in patients with…
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Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The exact aetiology of cluster headache is still unknown. Several studies show
a clear relationship between attacks, sleep and the circadian rhythm,
indicating a pivotal role of the hypothalamus. However, results up until now
have been inconsistent, mostly based upon single-night measurements in a
hospital setting with a limited number of samples. We will use advanced
ambulatory monitoring systems that have recently become available, allowing us
to measure multiple consecutive nights of sleep and 24-hour tissue cortisol &
melatonin rhythms (samples at 20 minute intervals). Unravelling the role of the
hypothalamus and increased knowledge of sleep and clock rhythms in cluster
headache will be of great value for follow-up studies on brain activity changes
underlying attack susceptibility, to test treatment with medication targeting
sleep and the biological clock, and to other researchers to investigate
evolving hypotheses.
Study objective
Part 1
To determine if certain sleep stages (wake, REM, N1, N2, N3), and relatively
high or low melatonin and cortisol levels, respectively, are associated with an
increased or decreased instantaneous risk of cluster headache attacks in
patients with either chronic or episodic cluster headache during the in bout
phase.
Part 2
To determine if the sleep stage distribution (percentage REM and non-REM), and
the average melatonin zenith (peak) and cortisol nadir (through) differ within
patients with episodic cluster headache in bout versus out of bout.
Study design
A single centre, prospective cohort study consisting of a one-week baseline
period, followed by 7 days of neurophysiological measurements during part 1
(CCH + ECH) and an additional 7 days of neurophysiological measurements during
part 2 (only ECH).
Study burden and risks
Participating in the study includes 4-5 (CCH) of 8-10 (ECH) visits to the LUMC,
filling out questionnaires, and 7 (CCH) or 14 days (ECH) of neurophysiological
measurements. During the first visit, the subcutaneous microdialysis catheter
will be placed. This can cause minor discomfort, but once the microdialysis
pump is connected, the hormone sampling will happen automatically without any
additional discomfort for the participant. All other measurements are
non-invasive. The measurements will be performed at home, minimising the burden
on participants, and risks are low. Participation in this study has no direct
benefits. However, the results can lead to new insights and subsequently
treatment options for cluster headache, and therefore indirectly benefit
participants.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84386.058.23 |