The Effect of Bright Light Therapy on Migraine With Sleep Disturbance
Primary Purpose
Migraine, Sleep Disturbance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Feel Bright Light
Sponsored by
About this trial
This is an interventional supportive care trial for Migraine focused on measuring migraine headache, bright light therapy, circadian rhythm, sleep hygiene, molecular biology
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BLT-1
BLT-2
Arm Description
Light therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks.
Placebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Change in sleep quantity as assessed by wrist actigraph
Mean change from baseline in total sleep time on the wrist actigraph at 4 weeks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04890691
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Anticipated)
Primary Completion Date
June 14, 2022 (Anticipated)
Study Completion Date
June 14, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hungkuang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Explore the clinical efficacy of bright light therapy for migraine prevention;
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Sleep Disturbance
Keywords
migraine headache, bright light therapy, circadian rhythm, sleep hygiene, molecular biology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This a randomized, double-blind, placebo-controlled clinical trial to explore the effects of light therapy for migraine combined with sleep disturbance.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BLT-1
Arm Type
Experimental
Arm Description
Light therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks.
Arm Title
BLT-2
Arm Type
Placebo Comparator
Arm Description
Placebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Feel Bright Light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of migraine episodes as assessed by Headache Diary
Description
Mean change from baseline in number of migraine episodes on the Headache Diary at 4 weeks.
Time Frame
post-intervention at Week 4.
Title
Change in sleep quality as assessed by General Sleep Disturbance Scale (GSDS)
Description
Mean change from baseline in sleep quality scores on the GSDS at 4 weeks.
Time Frame
post-intervention at Week 4.
Title
Change in sleep quantity as assessed by wrist actigraph
Description
Mean change from baseline in total sleep time on the wrist actigraph at 4 weeks.
Time Frame
post-intervention at Week 4.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Yu Lee, PhD
Phone
886426318652
Ext
7191
Email
slee103@hk.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Yu Lee, PhD
Phone
6787705118
Email
700light@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Yu Lee, PhD
Organizational Affiliation
Hungkuang University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
The Effect of Bright Light Therapy on Migraine With Sleep Disturbance
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