MigraineNCT04890691
The Effect of Bright Light Therapy on Migraine With Sleep Disturbance
A study testing Feel Bright Light in people with Migraine and Sleep Disturbance, run by Hungkuang University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Migraine, Sleep Disturbance
- What is being tested?
- Feel Bright Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 14 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
- Explore the clinical efficacy of bright light therapy for migraine prevention;
- Explore the underlying molecular and biochemical mechanisms of light therapy on migraine prevention.
Read the 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.
- Conditions
- Migraine, Sleep Disturbance
- Being tested
- Feel Bright Light
- Keywords
- migraine headache, bright light therapy, circadian rhythm, sleep hygiene, molecular biology
- Medical subject headings
- Migraine Disorders, Parasomnias, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feel Bright LightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BLT-1 | Experimental | Light therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks. Receives: Device: Feel Bright Light |
| BLT-2 | Placebo comparator | Placebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks. Receives: Device: Feel Bright Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: post-intervention at Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start15 Jun 2021 (estimated)
- Primary completion14 Jun 2022 (estimated)
- Study completion14 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Yu (Sylvia) Lee, PhD, RN, FAAN, Hungkuang University
- Investigators
- Shih-Yu Lee, PhD, Principal investigator, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890691
- Sponsor's protocol ID
- KTGH21002
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36742203
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bright Light Therapy on Migraine With Sleep Disturbance: the Role of Circadian Rhythms and Specific Biomarkers
- ClinicalTrials.gov ID
- NCT04890691
- Acronym / sponsor ID
- KTGH21002
- Conditions
- Migraine, Sleep Disturbance
- Keywords
- migraine headache, bright light therapy, circadian rhythm, sleep hygiene, molecular biology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 14 Jun 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This a randomized, double-blind, placebo-controlled clinical trial to explore the effects of light therapy for migraine combined with sleep disturbance.
| Arm | Type | Receives |
|---|---|---|
| BLT-1 | Experimental | Device: Feel Bright LightLight therapy (wavelengths between 470nm and 525nm), 30 minutes/day for 4 weeks. |
| BLT-2 | Placebo comparator | Device: Feel Bright LightPlacebo light (wavelength between 620nm and 750 nm), 30 minutes/day for 4 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The criteria for participation will be women:
Key exclusion criteria (6 listed)
- Women will be excluded from participation for any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feel Bright LightDuring 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. | Device | BLT-1, BLT-2 |
Primary outcome
Number of migraine episodes as assessed by Headache Diary
Time frame: post-intervention at Week 4.
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)
Time frame: post-intervention at Week 4.
Mean change from baseline in sleep quality scores on the GSDS at 4 weeks.
Change in sleep quantity as assessed by wrist actigraph
Time frame: post-intervention at Week 4.
Mean change from baseline in total sleep time on the wrist actigraph at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 36742203Lin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Yu Lee, PhD principal investigator
Hungkuang University
Questions about this trial
What is this clinical trial studying?
A study testing Feel Bright Light in people with Migraine and Sleep Disturbance, run by Hungkuang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Yu Lee, PhD (886426318652 ext. 7191, slee103@hk.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of migraine episodes as assessed by Headache Diary (time frame: post-intervention at Week 4.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.