An interventional study of use of Luminettes ® with active light emission and use of Luminettes ® with a light emission presumed to have no therapeutic effect in Cluster Headache, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 48 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Luminette® with active light emission in the 400 \< X \< 750 nm spectrum
Other: use of Luminettes ® with active light emission
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)
Other: use of Luminettes ® with a light emission presumed to have no therapeutic effect
Spectrum of 400 \< X \< 750 nm assumed active
Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 \< X \< 650 nm assumed to have no therapeutic effect
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.
Time frame: At day 28
Incidence and nature of adverse reactions
Headache, eye fatigue, dry eyes, nausea
Time frame: Daily
Intensity of cluster headache
mild, moderate, severe, very severe
Time frame: Daily
Use of acute treatments
sumatriptan and oxygen therapy
Time frame: Daily
Patient's Global Impression of Change (PGIC) score
From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated)
Time frame: At day 28
Plan to share: No
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