Actively Recruiting
Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-03-17
48
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cluster headache is a primary headache condition, with its chronic form often being hard to treat. This research investigates the use of light therapy, which has been applied in other chronobiological disorders like seasonal depression and migraine, to see if it can help reset biological rhythms and reduce chronic cluster headache attacks. The study is a proof-of-concept trial aimed at assessing the preventive effects of light therapy in patients with chronic cluster headache. Participants will use Luminette4 devices that emit light in different spectra. One group will receive active light therapy with wavelengths between 400 and 750 nm, while the control group will use a device emitting light between 560 and 650 nm, which is assumed to have no therapeutic effect. This treatment is delivered using a consumer electronics device and is randomized and double-blinded to compare the effects of the two light therapies. During the study, participants will be monitored for their weekly number of cluster headache attacks at day 28, along with daily reports of headache intensity, use of acute treatments, and any adverse reactions. Participants will also complete a Patient's Global Impression of Change score at day 28. The trial includes close assessment of safety and efficacy, with the total participation lasting at least 28 days of treatment and monitoring.
CONDITIONS
Brief Title
Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years old or more
- Diagnosis of chronic cluster headache according to ICHD-3 criteria
- At least 24 cluster headache attacks during baseline period
- Stable prophylactic treatment for at least 1 month and commitment not to change it during the study
- Affiliated with the French social security system
- Able to understand and speak French correctly
- Provided free and informed written consent
You will not qualify if you...
- Contraindication to light therapy such as use of photosensitizing treatment
- History of eye diseases including cataract, macular degeneration, glaucoma, or retinitis pigmentosa
- Working night shifts
- Other neurological, psychiatric, or developmental disorders incompatible with the study
- Current treatment of cluster headache with melatonin
- Persons protected by French Public Health Code articles L1121-5, L1121-6, and L1121-8 (e.g., pregnant or breastfeeding women, judicially deprived persons, socially vulnerable persons, adults unable to consent)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants use Luminettes® devices with either active light emission or a placebo light emission as part of their prophylactic treatment for chronic cluster headache.
Daily use and monitoring
Trial Site Locations
Total: 2 locations
1
Hopital La Timone
Marseille, France, 13005
Actively Recruiting
2
Hôpital de Cimiez
Nice, France, 06000
Not Yet Recruiting
Research Team
A
Anne DONNET
S
Sophie Tardoski
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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