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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01453-44 | Other Identifier | ID-RCB |
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Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.
This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.
Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (group 1) | Experimental | Luminette® with active light emission in the 400 < X < 750 nm spectrum |
|
| Control group (group 2) | Placebo Comparator | Luminette ® with modified spectral parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect (placebo effect) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of Luminettes ® with active light emission | Other | Spectrum of 400 < X < 750 nm assumed active |
|
| Measure | Description | Time Frame |
|---|---|---|
| The median weekly number of cluster headache attacks | The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms. | At day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of adverse reactions | Headache, eye fatigue, dry eyes, nausea | Daily |
| Intensity of cluster headache | mild, moderate, severe, very severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne DONNET | Contact | +33491384345 | anne.donnet@ap-hm.fr | |
| Sophie Tardoski | Contact | 0491381594 Ext. 33 | sophie.tardoski@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital La Timone | Recruiting | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| use of Luminettes ® with a light emission presumed to have no therapeutic effect | Other | Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect |
|
| Daily |
| Use of acute treatments | sumatriptan and oxygen therapy | Daily |
| Patient's Global Impression of Change (PGIC) score | From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated) | At day 28 |
| Hôpital de Cimiez | Not yet recruiting | Nice | 06000 | France |
|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |