Clinical trial NCT04439409: Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
Official title: AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cluster Headache
Keywords: Cluster Headache
Autonomic Nervous System
Seizure
Holter
Electrocardiogram
(LF/HF) ratio
Daytime seizure
Night seizure
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cluster Headache (CH) will be included.

Brief summary: Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise mechanism of Cluster Headache (CH) is still unknown. The question is whether these dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether they are the triggering factor.

Detailed description: This study cares about the evolution of the Autonomic Nervous System (ANS) in Cluster Headache (CH) seizures. Patients will be offered Holter ECG to study the temporal relationships between changes in Autonomic Nervous System (ANS) activity during Headache (CH) seizures and changes in Autonomic Nervous System (ANS) activity before and after seizure treatment, using heart rate variability measurement.

The hypothesis is that there would be an initial temporary sympathetic activation, followed quickly by parasympathetic hyperactivation and a return to a state of equilibrium.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Affiliated or entitled to a Social Security scheme
* Resident in the territories of the hospital grouping of Loire territory (located less than 50 km away)
* Whose diagnosis of episodic or chronic Cluster Headache (CH) has been confirmed according to International Classification of Headache Disorders (ICHD)- 3 criteria
* With a regular sinus rhythm and heart rate

Exclusion Criteria:

* Conditions contraindicating the use of injectable sumatriptan
* Conditions likely to affect the Autonomic Nervous System (ANS): dysautonomic sensory neuropathies, sleep apnea syndrome, etc.
* Cognitive or language disorders that may interfere with pain assessment and seizure follow-up.
* Patients taking treatments that may modify the Autonomic Nervous System (ANS): catecholamine (adrenaline, noradrenaline, dopamine), B-stimulants (isoprenaline, dobutamine, dopexamine, salbutamol, terbutaline, fenoterol, orciprenaline, clenbuterol, salmeterol, formoterol), B-blockers, alpha-stimulants (midodrine, alpha-methyl-dopa, clonidine, rilmenidine, moxonidine), alpha-blockers (phentolamine, prazosin, urapidil), amphetamine, tyramine, ephedrine, selegiline, cocaine, imipramine.
* Impossibility to submit to the medical follow-up of the program for geographical, social or psychological reasons.
* Patient deprived of liberty or under guardianship.
* Patient with preventive background treatment of Cluster Headache (CH).

Primary outcomes:
measure: Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
timeFrame: Day: 7
Secondary outcomes:
measure: Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure
timeFrame: Day: 7
measure: Low Frequency during daytime and night seizure
timeFrame: Day: 7
measure: High Frequency (HF) during daytime and night seizure
timeFrame: Day: 7
measure: Correlation between several parameters
timeFrame: Day: 7
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christelle CREAC'H, MD
role: PRINCIPAL_INVESTIGATOR
References: