NCT04890691

The Effect of Bright Light Therapy on Migraine With Sleep Disturbance

The Effect of Bright Light Therapy on Migraine With Sleep Disturbance: the Role of Circadian Rhythms and Specific Biomarkers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hungkuang University · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Migraine is a common disabling disorder and its substantial burden is associated with considerable negative impact on quality of life. Several pharmacological treatments are available for migraine prophylaxis but insufficient efficacy and significant side effects preclude them being widely using in migraine treatment. Recently, growing evidences have suggested that migraines are closely associated with sleep and circadian rhythms. Sleep disturbance is well-known as one of the triggers for migraine episode, and too much sleep (i.e., sleeping more on weekend) can also trigger migraine attacks. In addition, shift-work or jet lag have been reported to be triggers in some migraines; regular and good sleep would benefit migraine. Intriguing, hypothalamus is thought to be migraine generator and sleep and circadian activity rhythm also under controlled by hypothalamus. The evidence suggests an influence of both sleep and the circadian system with migraine. In the past, clinical evidence has shown that light therapy can stabilize the sleep architecture and further improve insomnia related to circadian rhythm disorders. However, the beneficial effect of light therapy on migraine with sleep disturbance has not yet been determined. This randomized, double-blinded, placebo-controlled study aim to: 1. Explore the clinical efficacy of bright light therapy for migraine prevention; 2. Explore the underlying molecular and biochemical mechanisms of light therapy on migraine prevention.

Detailed description

Migraine is a common disabling disorder and its substantial burden is associated with considerable negative impact on quality of life. Several pharmacological treatments are available for migraine prophylaxis but insufficient efficacy and significant side effects preclude them being widely using in migraine treatment. Recently, growing evidences have suggested that migraines are closely associated with sleep and circadian rhythms. Sleep disturbance is well-known as one of the triggers for migraine episode, and too much sleep (i.e., sleeping more on weekend) can also trigger migraine attacks. In addition, shift-work or jet lag have been reported to be triggers in some migraines; regular and good sleep would benefit migraine. Intriguing, hypothalamus is thought to be migraine generator and sleep and circadian activity rhythm also under controlled by hypothalamus. The evidence suggests an influence of both sleep and the circadian system with migraine. In the past, clinical evidence has shown that light therapy can stabilize the sleep architecture and further improve insomnia related to circadian rhythm disorders. However, the beneficial effect of light therapy on migraine with sleep disturbance has not yet been determined. Objectives: 1. To explore the clinical efficacy of bright light therapy for migraine prevention; 2. To explore the underlying molecular and biochemical mechanisms of light therapy on migraine prevention. Method: This project is a one-year, randomized, double-blinded, placebo-controlled clinical trial to explore the effects of light therapy for migraine combined will sleep disturbance. The study design includes a 4-week monitor (baseline and pre-test), a 4-week treatment period, and post-test. It is expected to recruited 60 study participants, aged 20-65, who have not received migraine treatment in the past month. The study participants will be required to receive the following assessment (1) headache assessments: headache structure questionnaires, headache diary, the Migraine Disability Assessment (MIDAS), patient overall impression questionnaire-migraine improvement questionnaire (PGI-I), patient overall impression questionnaire-migraine severity questionnaire (PGI-S), Hospital anxiety and depression scale (HADS), Migraine Quality of Life Questionnaire (MSQ); (2) sleep assessments: sleep diary, Pittsburgh Sleep Quality Questionnaire (PSQI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Polysomnography (PSG), wrist actigraph; and (3) a series of blood tests for serum biomarkers. Subjective and objective data from the pre- and post-test will be used to examine the clinical efficacy.

Conditions

• Migraine
• Sleep Disturbance

Interventions

Type	Name	Description
DEVICE	Feel Bright Light	During the first waking hour, the participants will be required to wear the light visor (either therapeutic or placebo light) for 30 minutes/day for 4 weeks.

Timeline

• Start date: 2021-06-15
• Primary completion: 2022-06-14
• Completion: 2023-06-14
• First posted: 2021-05-18
• Last updated: 2021-05-18