Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742191
Status:
RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-02-15
Brief Title:
The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches
Sponsor:
OSF Healthcare System
Organization:
OSF Healthcare System
Study Overview
Official Title:
The Effect of Daylight Saving Time Transitions on Sleep and Migraine Headaches
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DST
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-wearablecontactless 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 participants 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
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-wearablecontactless 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 participants 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 InstituteUniversity 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 80 and higher Cannot be set up from a computer
4 Subjects that can commit to sleep on the same bedmattress 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 subjects 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 httpswwwwithingscomusensleepshopgclidCjwKCAjwvNaYBhA3EiwACgndgn_LudRfkDgfsTm9vTfPyIaDs77O7c55PKJa0WZ3W4E0HFqwbIgLhBoCUIwQAvD_BwEgclsrcawds
The non-wearablecontactless 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 258 minutes PSG - 3666 612 and Withings device 3924 672 minutes acceptable precision The device estimated sleep efficiency very well when compared to the PSG PSG - 825 and Withings device 826
The app will be downloaded to the participants 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 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 80 and higher Cannot be set up from a computer
4 Subjects that can commit to sleep on the same bedmattress 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 subjects 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 httpswwwwithingscomusensleepshopgclidCjwKCAjwvNaYBhA3EiwACgndgn_LudRfkDgfsTm9vTfPyIaDs77O7c55PKJa0WZ3W4E0HFqwbIgLhBoCUIwQAvD_BwEgclsrcawds
The non-wearablecontactless 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 258 minutes PSG - 3666 612 and Withings device 3924 672 minutes acceptable precision The device estimated sleep efficiency very well when compared to the PSG PSG - 825 and Withings device 826
The app will be downloaded to the participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None