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Recruiting NCT06540651

NCT06540651 Efficacy of Light Therapy in Treatment of Chronic Cluster Headache

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Clinical Trial Summary
NCT ID NCT06540651
Status Recruiting
Phase
Sponsor Assistance Publique Hopitaux De Marseille
Condition Cluster Headache
Study Type INTERVENTIONAL
Enrollment 48 participants
Start Date 2025-02-06
Primary Completion 2027-02-05

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
use of Luminettes ® with active light emissionuse of Luminettes ® with a light emission presumed to have no therapeutic effect

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 48 participants in total. It began in 2025-02-06 with a primary completion date of 2027-02-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Male or female, of 18 years years old or more; * Diagnosis of chronic cluster headache according to ICHD-3 criteria; * Number of seizures during baseline equal to at least 24; * Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study; * Patient affiliated to the French social security system. * Patient who understands and speaks French correctly; * Patient who has given free and informed written consent. Exclusion Criteria: * Contraindication to the use of light therapy: use of a photosensitizing treatment; * Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa; * Patients who work at night; * Other neurological, psychiatric or developmental pathologies considered incompatible with the study; * Background treatment of cluster headache with melatonin; * Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).

Contact & Investigator

Central Contact

Anne DONNET

✉ anne.donnet@ap-hm.fr

📞 +33491384345

Frequently Asked Questions

Who can join the NCT06540651 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Cluster Headache. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06540651 currently recruiting?

Yes, NCT06540651 is actively recruiting participants. Contact the research team at anne.donnet@ap-hm.fr for enrollment information.

Where is the NCT06540651 trial being conducted?

This trial is being conducted at Marseille, France, Nice, France.

Who is sponsoring the NCT06540651 clinical trial?

NCT06540651 is sponsored by Assistance Publique Hopitaux De Marseille. The trial plans to enroll 48 participants.

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