MyVitalC: Sleep and Everyday Headache Management

Efforia, Inc

Status: Enrolling

Conditions: Headaches; Sleep

Treatments: Dietary Supplement: MyVitalC (ESS60 in Extra Virgin Olive Oil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07477236

48237

Details and patient eligibility

About

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.

Full 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/

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Single Arm longitudinal where participants act as their own control

Experimental group

Description:

Single Arm longitudinal where participants act as their own control

Treatment:

Dietary Supplement: MyVitalC (ESS60 in Extra Virgin Olive Oil)