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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
Hungkuang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

    First Posted
    May 10, 2021
    Last Updated
    May 13, 2021
    Sponsor
    Hungkuang University
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    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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