Episodic MigraineDSTNCT05742191
The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches.
An observational study of Episodic Migraine, run by OSF Healthcare System at 1 site in United States.
Trial summary
A prospective study that investigates the impact of circadian rhythm disturbances due to daylight saving time transitions on migraine patients. The Primary aim is to investigate the impact of springtime DST (March 12 2023 at 2 AM on Sunday) on sleep metrics in patients with migraine headaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Migraine
- What is being tested?
- Daylight Savings time transitions
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 1 Jun 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of episodic migraines.
Who may be able to join
- Age 18 years and older
- Episodic migraine diagnosis based on ICHD 3 criteria
- Subjects with smart phone who can download and use the Health Mate app available on iOS14 and higher and Android 8.0 and higher (Cannot be set up from a computer)
- Subjects that can commit to sleep on the same bed/mattress every night during the study period
- Subjects that can commit not to use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) that assist with sleep onset during the study period.
Who cannot join
- Patients who do not meet ICHD-3 diagnostic criteria for migraine
- Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
- Patients who regularly use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) to assist with sleep onset.
- Participants who are planning to initiate new treatment for sleep disorders during the study period.
- Subjects who participate in shift work.
Trial locations and contacts
1 site in 1 country.
Hrachya Nersesyan, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
A prospective study that investigates the impact of circadian rhythm disturbances due to daylight saving time transitions on migraine patients.
The Primary aim is to investigate the impact of springtime DST (March 12 2023 at 2 AM on Sunday) on sleep metrics in patients with migraine headaches. Secondary aim is to examine the association between incidence of migraine headaches and sleep metrics with time transitions.
Participants will be provided with a Withings non-wearable/contactless sleep tracker, which will be placed under the mattress for a period of 4 weeks (2 weeks before and 2 weeks after) during daylight saving time transition in March, 2023. Withings Health Mate app will be downloaded to the participant's smartphone to collect Sleep Data. Headache diaries will be provided to log the details of the migraines during the study period. Morningness - eveningness questionnaire (MEQ) will be used to categorize subjects on the chronotype spectrum.
Read the detailed description
This is a prospective study that investigates the impact of circadian rhythm disturbances due to time transitions on migraine patients. We will seek data analytics assistance to gather the list of subjects who meet the inclusion and exclusion criteria. A thorough review of the electronic medical records will be performed by the PIs to identify the appropriate participants. The Research coordinator will contact the subjects over the phone and discuss the study details. We will follow the numerical order (data as received by the analytics team) and stop contacting the subjects once we reach the target sample size of 50. Interested subjects will be invited to the study visit for formal consenting and the explanation of the study procedure. This study is designed to analyze the sleep metrics (total sleep time, sleep efficiency, sleep onset, and wake up time) in migraine patients with daylight saving spring transition. We will collect the demographics, information regarding migraine headache and Chrono type data to perform required data analysis at OSF HealthCare Illinois Neurological Institute/University of Illinois College of Medicine at Peoria.
Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of episodic migraines. A total of 50 subjects will be recruited in this study.
Inclusion criteria:
- Age 18 years and older
- Episodic migraine diagnosis based on ICHD 3 criteria
- Subjects with smart phone who can download and use the Health Mate app available on iOS14 and higher and Android 8.0 and higher (Cannot be set up from a computer)
- Subjects that can commit to sleep on the same bed/mattress every night during the study period
- Subjects that can commit not to use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) that assist with sleep onset during the study period.
Exclusion criteria:
- Patients who do not meet ICHD-3 diagnostic criteria for migraine
- Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
- Patients who regularly use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) to assist with sleep onset.
- Participants who are planning to initiate new treatment for sleep disorders during the study period.
- Subjects who participate in shift work.
The PI, Co PI and statisticians shall be the only individuals who will access data. The data will be de-identified at the source and no PHI shall remain connected to any subject's name, date of birth, medical record number, or any other personal information that could tie back to patients once the study is completed.
Withings, under the mattress sleep tracker, will be utilized to collect the sleep metrics in our study https://www.withings.com/us/en/sleep/shop?gclid=CjwKCAjwvNaYBhA3EiwACgndgn_LudRfkDgfsTm9vTfPyIaDs77O7c55PKJa0WZ3W4E0HFqwbIgLhBoCUIwQAvD_BwE\&gclsrc=aw.ds
The non-wearable/contactless sleep tracker will be placed under the mattress for a period of 4 weeks (2 weeks before and 2 weeks after) during daylight saving time transition in March, 2023. The device was validated for the detection of sleep apnea; a couple of sleep metrics showed good correlation with the gold standard polysomnogram (PSG) (Total sleep time and sleep efficiency). The Withings sleep tracking mat overestimated TST by 25.8 minutes (PSG - 366.6 (61.2) and Withings device 392.4 (67.2) minutes), acceptable precision. The device estimated sleep efficiency very well when compared to the PSG [PSG - 82.5% and Withings device 82.6%].
The app will be downloaded to the participant's smartphone. The Research Coordinator will contact the subjects who meet inclusion and exclusion criteria to explain the study procedure and obtain informed consent. Subjects will be taught how to download the app and send the data to the study personal at the initial visit. The non-wearable tracking device and the mobile app will be provided free of cost. Mobile app download data includes patient related information (demographics) and sleep metrics. Headache diaries will be provided to log the details of the migraines during the study period. Morningness - eveningness questionnaire (MEQ) will be used to categorize subjects on the chronotype spectrum.
- Conditions
- Episodic Migraine
- Being tested
- Daylight Savings time transitions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daylight Savings time transitionsOther
Daylight Savings time transitions.
| Study group | Role | What they receive |
|---|---|---|
| Established Clinic Patients at OSF INI with Episodic Migraine diagnosis. | Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of Episodic Migraine. Receives: Other: Daylight Savings time transitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm disturbances and alteration of total sleep time and sleep efficiency
To investigate the impact of springtime DST (March 12 2023 at 2 AM on Sunday) on sleep metrics in patients with migraine headaches.
Measured: 4 weeks
Secondary outcomes (1)
Migraine Headaches
To examine the association between incidence of migraine headaches and sleep metrics with time transitions.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start6 Feb 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Episodic 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikanth Gorantla, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742191
- Sponsor's protocol ID
- 1969211
- Acronym
- DST
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollaoglu M. Trigger factors in migraine patients. J Health Psychol. 2013 Jul;18(7):984-94. doi: 10.1177/1359105312446773. Epub 2012 Oct 26.
PubMed 23104993Song TJ, Yun CH, Cho SJ, Kim WJ, Yang KI, Chu MK. Short sleep duration and poor sleep quality among migraineurs: A population-based study. Cephalalgia. 2018 Apr;38(5):855-864. doi: 10.1177/0333102417716936. Epub 2017 Jun 22.
PubMed 28641451Strazisar BG, Strazisar L. Daylight Saving Time: Pros and Cons. Sleep Med Clin. 2021 Sep;16(3):523-531. doi: 10.1016/j.jsmc.2021.05.007. Epub 2021 Jul 2.
PubMed 34325828Rishi MA, Ahmed O, Barrantes Perez JH, Berneking M, Dombrowsky J, Flynn-Evans EE, Santiago V, Sullivan SS, Upender R, Yuen K, Abbasi-Feinberg F, Aurora RN, Carden KA, Kirsch DB, Kristo DA, Malhotra RK, Martin JL, Olson EJ, Ramar K, Rosen CL, Rowley JA, Shelgikar AV, Gurubhagavatula I. Daylight saving time: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2020 Oct 15;16(10):1781-1784. doi: 10.5664/jcsm.8780.
PubMed 32844740Kantermann T, Juda M, Merrow M, Roenneberg T. The human circadian clock's seasonal adjustment is disrupted by daylight saving time. Curr Biol. 2007 Nov 20;17(22):1996-2000. doi: 10.1016/j.cub.2007.10.025. Epub 2007 Oct 25.
PubMed 17964164Roenneberg T, Winnebeck EC, Klerman EB. Daylight Saving Time and Artificial Time Zones - A Battle Between Biological and Social Times. Front Physiol. 2019 Aug 7;10:944. doi: 10.3389/fphys.2019.00944. eCollection 2019.
PubMed 31447685Lahti TA, Leppamaki S, Lonnqvist J, Partonen T. Transition to daylight saving time reduces sleep duration plus sleep efficiency of the deprived sleep. Neurosci Lett. 2006 Oct 9;406(3):174-7. doi: 10.1016/j.neulet.2006.07.024. Epub 2006 Aug 22.
PubMed 16930838Tyler J, Fang Y, Goldstein C, Forger D, Sen S, Burmeister M. Genomic heterogeneity affects the response to Daylight Saving Time. Sci Rep. 2021 Jul 20;11(1):14792. doi: 10.1038/s41598-021-94459-z.
PubMed 34285349Sipila JO, Ruuskanen JO, Rautava P, Kyto V. Changes in ischemic stroke occurrence following daylight saving time transitions. Sleep Med. 2016 Nov-Dec;27-28:20-24. doi: 10.1016/j.sleep.2016.10.009. Epub 2016 Nov 2.
PubMed 27938913Chudow JJ, Dreyfus I, Zaremski L, Mazori AY, Fisher JD, Di Biase L, Romero J, Ferrick KJ, Krumerman A. Changes in atrial fibrillation admissions following daylight saving time transitions. Sleep Med. 2020 May;69:155-158. doi: 10.1016/j.sleep.2020.01.018. Epub 2020 Jan 27.
PubMed 32088351Prats-Uribe A, Tobias A, Prieto-Alhambra D. Excess Risk of Fatal Road Traffic Accidents on the Day of Daylight Saving Time Change. Epidemiology. 2018 Sep;29(5):e44-e45. doi: 10.1097/EDE.0000000000000865. No abstract available.
PubMed 29864085Fritz J, VoPham T, Wright KP Jr, Vetter C. A Chronobiological Evaluation of the Acute Effects of Daylight Saving Time on Traffic Accident Risk. Curr Biol. 2020 Feb 24;30(4):729-735.e2. doi: 10.1016/j.cub.2019.12.045. Epub 2020 Jan 30.
PubMed 32008905Hook J, Smith K, Andrew E, Ball J, Nehme Z. Daylight savings time transitions and risk of out-of-hospital cardiac arrest: An interrupted time series analysis. Resuscitation. 2021 Nov;168:84-90. doi: 10.1016/j.resuscitation.2021.09.021. Epub 2021 Sep 24.
PubMed 34571135Yadav RK, Kalita J, Misra UK. A study of triggers of migraine in India. Pain Med. 2010 Jan;11(1):44-7. doi: 10.1111/j.1526-4637.2009.00725.x. Epub 2009 Sep 29.
PubMed 19793343Haque B, Rahman KM, Hoque A, Hasan AT, Chowdhury RN, Khan SU, Alam MB, Habib M, Mohammad QD. Precipitating and relieving factors of migraine versus tension type headache. BMC Neurol. 2012 Aug 25;12:82. doi: 10.1186/1471-2377-12-82.
PubMed 22920541
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches.
- ClinicalTrials.gov ID
- NCT05742191
- Acronym / sponsor ID
- DST / 1969211
- Conditions
- Episodic Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 23 Feb 2023 (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.
A prospective study that investigates the impact of circadian rhythm disturbances due to daylight saving time transitions on migraine patients.
The Primary aim is to investigate the impact of springtime DST (March 12 2023 at 2 AM on Sunday) on sleep metrics in patients with migraine headaches. Secondary aim is to examine the association between incidence of migraine headaches and sleep metrics with time transitions.
Participants will be provided with a Withings non-wearable/contactless sleep tracker, which will be placed under the mattress for a period of 4 weeks (2 weeks before and 2 weeks after) during daylight saving time transition in March, 2023. Withings Health Mate app will be downloaded to the participant's smartphone to collect Sleep Data. Headache diaries will be provided to log the details of the migraines during the study period. Morningness - eveningness questionnaire (MEQ) will be used to categorize subjects on the chronotype spectrum.
Detailed description
This is a prospective study that investigates the impact of circadian rhythm disturbances due to time transitions on migraine patients. We will seek data analytics assistance to gather the list of subjects who meet the inclusion and exclusion criteria. A thorough review of the electronic medical records will be performed by the PIs to identify the appropriate participants. The Research coordinator will contact the subjects over the phone and discuss the study details. We will follow the numerical order (data as received by the analytics team) and stop contacting the subjects once we reach the target sample size of 50. Interested subjects will be invited to the study visit for formal consenting and the explanation of the study procedure. This study is designed to analyze the sleep metrics (total sleep time, sleep efficiency, sleep onset, and wake up time) in migraine patients with daylight saving spring transition. We will collect the demographics, information regarding migraine headache and Chrono type data to perform required data analysis at OSF HealthCare Illinois Neurological Institute/University of Illinois College of Medicine at Peoria.
Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of episodic migraines. A total of 50 subjects will be recruited in this study.
Inclusion criteria:
- Age 18 years and older
- Episodic migraine diagnosis based on ICHD 3 criteria
- Subjects with smart phone who can download and use the Health Mate app available on iOS14 and higher and Android 8.0 and higher (Cannot be set up from a computer)
- Subjects that can commit to sleep on the same bed/mattress every night during the study period
- Subjects that can commit not to use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) that assist with sleep onset during the study period.
Exclusion criteria:
- Patients who do not meet ICHD-3 diagnostic criteria for migraine
- Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
- Patients who regularly use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) to assist with sleep onset.
- Participants who are planning to initiate new treatment for sleep disorders during the study period.
- Subjects who participate in shift work.
The PI, Co PI and statisticians shall be the only individuals who will access data. The data will be de-identified at the source and no PHI shall remain connected to any subject's name, date of birth, medical record number, or any other personal information that could tie back to patients once the study is completed.
Withings, under the mattress sleep tracker, will be utilized to collect the sleep metrics in our study https://www.withings.com/us/en/sleep/shop?gclid=CjwKCAjwvNaYBhA3EiwACgndgn_LudRfkDgfsTm9vTfPyIaDs77O7c55PKJa0WZ3W4E0HFqwbIgLhBoCUIwQAvD_BwE\&gclsrc=aw.ds
The non-wearable/contactless sleep tracker will be placed under the mattress for a period of 4 weeks (2 weeks before and 2 weeks after) during daylight saving time transition in March, 2023. The device was validated for the detection of sleep apnea; a couple of sleep metrics showed good correlation with the gold standard polysomnogram (PSG) (Total sleep time and sleep efficiency). The Withings sleep tracking mat overestimated TST by 25.8 minutes (PSG - 366.6 (61.2) and Withings device 392.4 (67.2) minutes), acceptable precision. The device estimated sleep efficiency very well when compared to the PSG [PSG - 82.5% and Withings device 82.6%].
The app will be downloaded to the participant's smartphone. The Research Coordinator will contact the subjects who meet inclusion and exclusion criteria to explain the study procedure and obtain informed consent. Subjects will be taught how to download the app and send the data to the study personal at the initial visit. The non-wearable tracking device and the mobile app will be provided free of cost. Mobile app download data includes patient related information (demographics) and sleep metrics. Headache diaries will be provided to log the details of the migraines during the study period. Morningness - eveningness questionnaire (MEQ) will be used to categorize subjects on the chronotype spectrum.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Established Clinic Patients at OSF INI with Episodic Migraine diagnosis. | – | Other: Daylight Savings time transitionsStudy subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of Episodic Migraine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of episodic migraines.
Key inclusion criteria (5 listed)
- Age 18 years and older
- Episodic migraine diagnosis based on ICHD 3 criteria
- Subjects with smart phone who can download and use the Health Mate app available on iOS14 and higher and Android 8.0 and higher (Cannot be set up from a computer)
- Subjects that can commit to sleep on the same bed/mattress every night during the study period
- Subjects that can commit not to use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) that assist with sleep onset during the study period.
Key exclusion criteria (5 listed)
- Patients who do not meet ICHD-3 diagnostic criteria for migraine
- Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
- Patients who regularly use sleep aids (either prescription or over the counter sleep aids) or sedating medications (sedating anti-depressants, benzodiazepines, anti-histamines, anti-psychotics or gabapentinoids) to assist with sleep onset.
- Participants who are planning to initiate new treatment for sleep disorders during the study period.
- Subjects who participate in shift work.
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 |
|---|---|---|
| Daylight Savings time transitionsDaylight Savings time transitions. | Other | Established Clinic Patients at OSF INI with Episodic Migraine diagnosis. |
Primary outcome
Circadian rhythm disturbances and alteration of total sleep time and sleep efficiency
Time frame: 4 weeks
To investigate the impact of springtime DST (March 12 2023 at 2 AM on Sunday) on sleep metrics in patients with migraine headaches.
1 secondary outcome
Migraine Headaches
Time frame: 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Results publication: PubMed 23104993Mollaoglu M. Trigger factors in migraine patients. J Health Psychol. 2013 Jul;18(7):984-94. doi: 10.1177/1359105312446773. Epub 2012 Oct 26.
- Results publication: PubMed 28641451Song TJ, Yun CH, Cho SJ, Kim WJ, Yang KI, Chu MK. Short sleep duration and poor sleep quality among migraineurs: A population-based study. Cephalalgia. 2018 Apr;38(5):855-864. doi: 10.1177/0333102417716936. Epub 2017 Jun 22.
- Results publication: PubMed 34325828Strazisar BG, Strazisar L. Daylight Saving Time: Pros and Cons. Sleep Med Clin. 2021 Sep;16(3):523-531. doi: 10.1016/j.jsmc.2021.05.007. Epub 2021 Jul 2.
- Results publication: PubMed 32844740Rishi MA, Ahmed O, Barrantes Perez JH, Berneking M, Dombrowsky J, Flynn-Evans EE, Santiago V, Sullivan SS, Upender R, Yuen K, Abbasi-Feinberg F, Aurora RN, Carden KA, Kirsch DB, Kristo DA, Malhotra RK, Martin JL, Olson EJ, Ramar K, Rosen CL, Rowley JA, Shelgikar AV, Gurubhagavatula I. Daylight saving time: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2020 Oct 15;16(10):1781-1784. doi: 10.5664/jcsm.8780.
- Results publication: PubMed 17964164Kantermann T, Juda M, Merrow M, Roenneberg T. The human circadian clock's seasonal adjustment is disrupted by daylight saving time. Curr Biol. 2007 Nov 20;17(22):1996-2000. doi: 10.1016/j.cub.2007.10.025. Epub 2007 Oct 25.
- Results publication: PubMed 31447685Roenneberg T, Winnebeck EC, Klerman EB. Daylight Saving Time and Artificial Time Zones - A Battle Between Biological and Social Times. Front Physiol. 2019 Aug 7;10:944. doi: 10.3389/fphys.2019.00944. eCollection 2019.
- Results publication: PubMed 16930838Lahti TA, Leppamaki S, Lonnqvist J, Partonen T. Transition to daylight saving time reduces sleep duration plus sleep efficiency of the deprived sleep. Neurosci Lett. 2006 Oct 9;406(3):174-7. doi: 10.1016/j.neulet.2006.07.024. Epub 2006 Aug 22.
- Results publication: PubMed 34285349Tyler J, Fang Y, Goldstein C, Forger D, Sen S, Burmeister M. Genomic heterogeneity affects the response to Daylight Saving Time. Sci Rep. 2021 Jul 20;11(1):14792. doi: 10.1038/s41598-021-94459-z.
- Results publication: PubMed 27938913Sipila JO, Ruuskanen JO, Rautava P, Kyto V. Changes in ischemic stroke occurrence following daylight saving time transitions. Sleep Med. 2016 Nov-Dec;27-28:20-24. doi: 10.1016/j.sleep.2016.10.009. Epub 2016 Nov 2.
- Results publication: PubMed 32088351Chudow JJ, Dreyfus I, Zaremski L, Mazori AY, Fisher JD, Di Biase L, Romero J, Ferrick KJ, Krumerman A. Changes in atrial fibrillation admissions following daylight saving time transitions. Sleep Med. 2020 May;69:155-158. doi: 10.1016/j.sleep.2020.01.018. Epub 2020 Jan 27.
- Results publication: PubMed 29864085Prats-Uribe A, Tobias A, Prieto-Alhambra D. Excess Risk of Fatal Road Traffic Accidents on the Day of Daylight Saving Time Change. Epidemiology. 2018 Sep;29(5):e44-e45. doi: 10.1097/EDE.0000000000000865. No abstract available.
- Results publication: PubMed 32008905Fritz J, VoPham T, Wright KP Jr, Vetter C. A Chronobiological Evaluation of the Acute Effects of Daylight Saving Time on Traffic Accident Risk. Curr Biol. 2020 Feb 24;30(4):729-735.e2. doi: 10.1016/j.cub.2019.12.045. Epub 2020 Jan 30.
- Individual participant dataSharing planned: No
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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.
Hrachya Nersesyan, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Episodic Migraine, run by OSF Healthcare System at 1 site in United States.
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 5 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Sasikanth Gorantla, MD (3096244000, Sasikanth.Gorantla@osfhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian rhythm disturbances and alteration of total sleep time and sleep efficiency (time frame: 4 weeks). 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 NCT05742191, which also lists 20 linked publications.
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 23 Feb 2023.