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

Episodic Migraine Clinical Trial

— DST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742191
• Other study ID #: 1969211
• Status: Recruiting
• Start date: February 6, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: February 2023
• Source: OSF Healthcare System
• Contact: Sasikanth Gorantla, MD
• Phone: 3096244000
• Email: Sasikanth.Gorantla[@]osfhealthcare.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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_LudRfkDgfsTm9vTfPy IaDs77O7c55PKJa0WZ3W4E0HFqwbIgLhBoCUIwQAvD_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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Headache
• Migraine Disorders

Intervention

Other:
• Daylight Savings time transitions
Daylight Savings time transitions.

Locations

Country	Name	City	State
United States	OSF HealthCare Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (20)

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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. Erratum In: Front Physiol. 2019 Sep 1 — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Migraine Headaches	To examine the association between incidence of migraine headaches and sleep metrics with time transitions.	4 weeks.