Clinical trial NCT05742191: The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches.
Official title: The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Episodic Migraine
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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:

1. Age 18 years and older
2. Episodic migraine diagnosis based on ICHD 3 criteria
3. 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)
4. Subjects that can commit to sleep on the same bed/mattress every night during the study period
5. 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:

1. Patients who do not meet ICHD-3 diagnostic criteria for migraine
2. Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
3. 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.
4. Participants who are planning to initiate new treatment for sleep disorders during the study period.
5. 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and older
2. Episodic migraine diagnosis based on ICHD 3 criteria
3. 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)
4. Subjects that can commit to sleep on the same bed/mattress every night during the study period
5. 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:

1. Patients who do not meet ICHD-3 diagnostic criteria for migraine
2. Patients with migraine diagnosis who are suspected or confirmed to have active medication overuse headaches during the study period.
3. 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.
4. Participants who are planning to initiate new treatment for sleep disorders during the study period.
5. Subjects who participate in shift work.

Primary outcomes:
measure: Circadian rhythm disturbances and alteration of total sleep time and sleep efficiency
timeFrame: 4 weeks
Secondary outcomes:
measure: Migraine Headaches
timeFrame: 4 weeks.
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF HealthCare Saint Francis Medical Center
state: Illinois
Study officials:
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