The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches.

NCT05742191 | Unknown

• 1 other identifier: 1969211
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Migraine Headaches

  4 weeks.

Study Arms (1)

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.

Other: Daylight Savings time transitions

Interventions

Daylight Savings time transitions OTHER

Daylight Savings time transitions.

Established Clinic Patients at OSF INI with Episodic Migraine diagnosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be established clinic patients at OSF HealthCare INI neurological institute with a diagnosis of episodic migraines.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Related Publications (20)

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  PMID: 23104993 RESULT

• Song 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.

  PMID: 28641451 RESULT

• Strazisar 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.

  PMID: 34325828 RESULT

• Rishi 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.

  PMID: 32844740 RESULT

• Kantermann 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.

  PMID: 17964164 RESULT

• Roenneberg 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.

  PMID: 31447685 RESULT

• Lahti 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.

  PMID: 16930838 RESULT

• Tyler 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.

  PMID: 34285349 RESULT

• Sipila 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.

  PMID: 27938913 RESULT

• Chudow 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.

  PMID: 32088351 RESULT

• Prats-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.

  PMID: 29864085 RESULT

• Fritz 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.

  PMID: 32008905 RESULT

• Hook 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.

  PMID: 34571135 RESULT

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  PMID: 22920541 RESULT

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  PMID: 32631251 RESULT

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  PMID: 33590821 RESULT

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Central Study Contacts

Sasikanth Gorantla, MD

CONTACT

3096244000; Sasikanth.Gorantla@osfhealthcare.org

Hrachya Nersesyan, MD, PhD

CONTACT

Hrachya.Nersesyan@ini.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist and Sleep Medicine Physician

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 23, 2023
• Study Start: February 6, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 1, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)