Recruiting

Observational Study

Sponsor:

OSF Healthcare System

Code:

NCT05742191

Conditions

Episodic Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daylight Savings time transitions

Study Details

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

Study ID

NCT05742191

Start date

Feb 6, 2023

Status verified date

Feb, 2023

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Daylight Savings time transitions

Daylight Savings time transitions.

Primary outcome measure

  • Circadian rhythm disturbances and alteration of total sleep time and sleep efficiency [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Sasikanth Gorantla, MD

3096244000Sasikanth.Gorantla@osfhealthcare.org

Hrachya Nersesyan, MD, PhD

Hrachya.Nersesyan@ini.org

Locations

OSF HealthCare Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

More Information

Sponsor

OSF Healthcare System

Last update posted

Feb 23, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OSF Healthcare System on 2023-02-23.