The Effect of Bright Light Therapy on Migraine With Sleep Disturbance
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2023
CompletedMay 18, 2021
May 1, 2021
12 months
May 10, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Study Arms (2)
BLT-1
EXPERIMENTALLight therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks.
BLT-2
PLACEBO COMPARATORPlacebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lin TH, Yang CC, Lee SY, Chang CM, Tsai IJ, Wei CY, Yang CP. The effect of bright light therapy in migraine patients with sleep disturbance: A prospective, observational cohort study protocol. Front Aging Neurosci. 2023 Jan 19;14:1041076. doi: 10.3389/fnagi.2022.1041076. eCollection 2022.
PMID: 36742203DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shih-Yu Lee, PhD
Hungkuang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 18, 2021
Study Start
June 15, 2021
Primary Completion
June 14, 2022
Study Completion
June 14, 2023
Last Updated
May 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.