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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Sleep Disturbance
• Intervention / Treatment: Device: Feel Bright Light

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Yu Lee, PhD; Phone Number: 7191 886426318652; Email: slee103@hk.edu.tw
• Study Contact Backup: Name: Shih-Yu Lee, PhD; Phone Number: 6787705118; Email: 700light@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLT-1; Light therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks.	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.
Placebo Comparator: BLT-2; Placebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of migraine episodes as assessed by Headache Diary	Mean change from baseline in number of migraine episodes on the Headache Diary at 4 weeks.	post-intervention at Week 4.
Change in sleep quality as assessed by General Sleep Disturbance Scale (GSDS)	Mean change from baseline in sleep quality scores on the GSDS at 4 weeks.	post-intervention at Week 4.
Change in sleep quantity as assessed by wrist actigraph	Mean change from baseline in total sleep time on the wrist actigraph at 4 weeks.	post-intervention at Week 4.

Collaborators and Investigators

• Sponsor: Hungkuang University
• Investigators: Principal Investigator: Shih-Yu Lee, PhD, Hungkuang University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2021
• Primary Completion (Anticipated): June 14, 2022
• Study Completion (Anticipated): June 14, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 13, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: sleep hygiene; circadian rhythm; migraine headache; bright light therapy; molecular biology
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Headache Disorders, Primary; Headache Disorders; Dyssomnias; Parasomnias; Migraine Disorders
• Other Study ID Numbers: KTGH21002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will create a database at the School of Nursing (SON), Hungkuang University (HKU). Thus data sharing is expected for the main studies at SON, as well as any other project's using SON and HKU as resources. The data sharing plan has three components. First data sharing is planned within the HKU's projects and co-investigators in order to maximize the effort of both investigators and participants, through the use of shared instruments and a shared database. Second, these shared datasets will be shared, in de-identified fashion with internal HKU investigators during the life of the project. Third, de-identified data will be made available to external investigators, with a user agreement to protect confidentiality of human subjects.
• IPD Sharing Time Frame: Data will be made available to internal users as soon as the main database is closed and the primary analyses completed, likely at the end of year 2022. Data will be available to outside investigators within 6 months of publication of the primary analyses from the study.
• IPD Sharing Access Criteria: The user must agree the following data-sharing agreement: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No