Clinical trial NCT04890691: The Effect of Bright Light Therapy on Migraine With Sleep Disturbance
Official title: The Effect of Bright Light Therapy on Migraine With Sleep Disturbance: the Role of Circadian Rhythms and Specific Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Sleep Disturbance
Keywords: migraine headache
bright light therapy
circadian rhythm
sleep hygiene
molecular biology
Lead sponsor: Hungkuang University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This a randomized, double-blind, placebo-controlled clinical trial to explore the effects of light therapy for migraine combined with sleep disturbance.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The criteria for participation will be women:

  1. who aged between 20 and 65 years old.
  2. with a history of migraine headache and poor sleep quality (screen by using PSQI: Pittsburgh Sleep Quality Index).
  3. willing to participate for 9 weeks data collection, including self-reported questionnaires, monitor sleep (7-days wrist actigrpy and overnight polysomnography), and blood sample.
  4. not allergic to metal, which would be a contradiction for wearing the wrist actigraph.

Exclusion Criteria:

* Women will be excluded from participation for any of the following:

  1. have a history of trauma brain injury.
  2. history of alcoholism in the past year.
  3. pregnant or breastfeeding women.
  4. sensitive to light.
  5. history of using the following medicine in the past month: beta-blockers, antiepileptic, calcium ion blockers, antidepressants, hormone therapy.

Primary outcomes:
measure: Number of migraine episodes as assessed by Headache Diary
timeFrame: post-intervention at Week 4.
measure: Change in sleep quality as assessed by General Sleep Disturbance Scale (GSDS)
timeFrame: post-intervention at Week 4.
measure: Change in sleep quantity as assessed by wrist actigraph
timeFrame: post-intervention at Week 4.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hungkuang University
name: Shih-Yu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: