Headaches, Sleep
Conditions
Keywords
Sleep, Headaches
Brief summary
Sleep disturbance and recurring headaches can negatively affect daily functioning, mood, and productivity. MyVitalC (ESS60 in extra virgin olive oil) is a commercially available dietary supplement that has generated anecdotal claims related to sleep quality and headache relief; however, human data remain limited. This real-world observational study is designed to help participants evaluate whether use of MyVitalC is associated with changes in sleep disturbance and headache frequency or severity in their own daily lives. Participants will complete a four-week baseline observation period without the intervention, followed by six weeks of daily MyVitalC use, with weekly self-reported assessments. Participants serve as their own control, allowing for within-person comparison of outcomes before and during product use.
Detailed description
This single-arm observational study uses a structured baseline-plus-intervention design to assess within-participant changes in sleep disturbance and everyday headache outcomes associated with MyVitalC use. Participants first complete a four-week baseline period during which no study intervention is taken. During this time, participants complete weekly assessments to characterize their typical sleep disturbance and headache patterns. Following baseline, participants begin daily use of MyVitalC for six weeks and continue completing weekly assessments. The study employs validated patient-reported outcome measures, including the PROMIS Sleep Disturbance Scale and PROMIS Pain Interference Scale, as well as a custom Weekly Headache Check-In. Data will be used to generate individual-level comparisons between baseline and during-use periods. The study is designed as a signal-detection and personal-outcome evaluation trial rather than a randomized controlled efficacy study. More information can be found at the study recruitment landing page: https://app.efforia.com/myvitalc-sleep-migraine-management/
Interventions
DIETARY_SUPPLEMENTMyVitalC (ESS60 in Extra Virgin Olive Oil)
Participants will take 1 teaspoon (5 mL) of MyVitalC, ESS60 in extra virgin olive oil, orally once daily in the morning, with or without food, for six weeks. Daily intake is logged within the study platform.
Sponsors
Efforia, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants serve as their own control using an extended baseline observation period followed by an intervention period. Outcomes during MyVitalC use are compared against each participant's own baseline averages.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Adults of legal age of consent * Able to provide informed consent * Willing to complete weekly assessments and daily logs * Able to purchase and use the study product
Exclusion criteria
* Have known allergies to olive oil or product components * Are pregnant or breastfeeding * Have severe or chronic headache disorders * Have significant gastrointestinal conditions * Have medical conditions that could be exacerbated by supplement use * Have concerns about dizziness, fatigue, or mood disturbances * Are subject to organizational or legal restrictions on supplement use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Disturbance | Weekly during baseline (4 weeks) and weekly during intervention (6 weeks) | Measure: PROMIS Sleep Disturbance Scale Description: Assesses perceived sleep quality, sleep depth, and sleep-related difficulties. Higher scores indicate greater sleep disturbance. |
| Change in Headache Frequency | Weekly during baseline and intervention, and on day 70 (end of study) | Measure: Weekly Headache Check-In (frequency count) Description: Number of headaches experienced in the past 7 days. |
| Change in Headache Severity | Weekly during baseline and intervention, and on day 70 (end of study) | Measure: Weekly Headache Check-In (severity rating) Description: Participant-reported severity of the worst headache experienced during the past 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | Baseline and day 70 (end of study) | Measure: PROMIS Pain Interference Scale Description: Assesses the extent to which pain interferes with daily activities and functioning. |
Countries
United States
Contacts
CONTACTMatthew Amsden
Outcome results
None listed