Cluster HeadacheAVASNANCT04439409
Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
An observational study of Cluster Headache, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Holter electrocardiogram
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2020to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Cluster Headache (CH) will be included.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
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.
Read the 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.
- Conditions
- Cluster Headache
- Being tested
- Holter electrocardiogram
- Keywords
- Cluster Headache, Autonomic Nervous System, Seizure, Holter, Electrocardiogram, (LF/HF) ratio, Daytime seizure, Night seizure
- Medical subject headings
- Cluster Headache, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter electrocardiogramDevice
Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cluster Headache (CH) | Patients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days. Receives: Device: Holter electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.
Measured: Day: 7
Secondary outcomes (4)
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure
Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure during the basal period, pre-seizure, seizure and after the seizure.
Measured: Day: 7
Low Frequency during daytime and night seizure
Comparison of measure of Low Frequency during daytime and night seizure.
Measured: Day: 7
High Frequency (HF) during daytime and night seizure
Comparison of measure of High Frequency (HF) during daytime and night seizure.
Measured: Day: 7
Correlation between several parameters
Correlation between Heart Rate Variability (HRV), changes in the Low Frequency/High Frequency (LF/HF) ratio, the Low Frequency (LF) and the High Frequency (HF), and the intensity of pain measured on the Visual Analog Scale (VAS).
Measured: Day: 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start19 Aug 2020
- Primary completion7 Dec 2021
- Study completion15 Dec 2021
Why it stopped: No inclusions for 2 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle CREAC'H, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439409
- Sponsor's protocol ID
- 19CH103
- Other IDs
- 2019-A01343-54
- Acronym
- AVASNA
- Status last verified
- Apr 2023
- First submitted
- 18 Jun 2020
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).
- ClinicalTrials.gov ID
- NCT04439409
- Acronym / sponsor ID
- AVASNA / 19CH103
- Conditions
- Cluster Headache
- Keywords
- Cluster Headache, Autonomic Nervous System, Seizure, Holter, Electrocardiogram, (LF/HF) ratio, Daytime seizure, Night seizure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No inclusions for 2 years
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cluster Headache (CH) | – | Device: Holter electrocardiogramPatients with Cluster Headache (CH) will be included. They will have a Holter electrocardiogram during 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cluster Headache (CH) will be included.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter electrocardiogramHolter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously. | Device | Patients with Cluster Headache (CH) |
Primary outcome
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure
Time frame: Day: 7
Comparison of the Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure during the basal period, pre-seizure, seizure and after the seizure.
4 secondary outcomes
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first daytime seizure
Time frame: Day: 7
Low Frequency during daytime and night seizure
Time frame: Day: 7
High Frequency (HF) during daytime and night seizure
Time frame: Day: 7
Correlation between several parameters
Time frame: Day: 7
Results and safety
The study was stopped early (reason given: No inclusions for 2 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle CREAC'H, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No inclusions for 2 years). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Frequency/High Frequency (LF/HF) ratio at the onset of the first night seizure (time frame: Day: 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.