The Effect of Bright Light Therapy on Migraine With Sleep Disturbance: the Role of Circadian Rhythms and Specific Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Number of migraine episodes as assessed by Headache Diary
研究概览
简要总结
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:
- Explore the clinical efficacy of bright light therapy for migraine prevention;
- Explore the underlying molecular and biochemical mechanisms of light therapy on migraine prevention.
详细描述
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:
- To explore the clinical efficacy of bright light therapy for migraine prevention;
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants in both groups will receive light therapy to mask their status in the treatment (BLT-1, therapeutic light) or control (BLT-2, placebo light) group.
Participants will use a special ID to mask the PI to identify who is in the treatment group.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The criteria for participation will be women:
- •who aged between 20 and 65 years old.
- •with a history of migraine headache and poor sleep quality (screen by using PSQI: Pittsburgh Sleep Quality Index).
- •willing to participate for 9 weeks data collection, including self-reported questionnaires, monitor sleep (7-days wrist actigrpy and overnight polysomnography), and blood sample.
- •not allergic to metal, which would be a contradiction for wearing the wrist actigraph.
排除标准
- •Women will be excluded from participation for any of the following:
- •have a history of trauma brain injury.
- •history of alcoholism in the past year.
- •pregnant or breastfeeding women.
- •sensitive to light.
- •history of using the following medicine in the past month: beta-blockers, antiepileptic, calcium ion blockers, antidepressants, hormone therapy.
研究组 & 干预措施
BLT-1
Light therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks.
干预措施: Feel Bright Light (Device)
BLT-2
Placebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks.
干预措施: Feel Bright Light (Device)
结局指标
主要结局
Number of migraine episodes as assessed by Headache Diary
时间窗: post-intervention at Week 4.
Mean change from baseline in number of migraine episodes on the Headache Diary at 4 weeks.
Change in sleep quantity as assessed by wrist actigraph
时间窗: post-intervention at Week 4.
Mean change from baseline in total sleep time on the wrist actigraph at 4 weeks.
Change in sleep quality as assessed by General Sleep Disturbance Scale (GSDS)
时间窗: post-intervention at Week 4.
Mean change from baseline in sleep quality scores on the GSDS at 4 weeks.
次要结局
未报告次要终点
研究者
Shih-Yu (Sylvia) Lee, PhD, RN, FAAN
Professor
Hungkuang University