MyVitalC: Sleep and Everyday Headache Management

March 13, 2026 updated by: Efforia, Inc

A Real-World, Single-Arm Observational Study Evaluating the Effects of MyVitalC (ESS60 in Extra Virgin Olive Oil) on Sleep Disturbance and Everyday Headaches

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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/

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Efforia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm longitudinal where participants act as their own control
Dietary supplement: MyVitalC (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Disturbance
Time Frame: 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.
Weekly during baseline (4 weeks) and weekly during intervention (6 weeks)
Change in Headache Frequency
Time Frame: 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.
Weekly during baseline and intervention, and on day 70 (end of study)
Change in Headache Severity
Time Frame: 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.
Weekly during baseline and intervention, and on day 70 (end of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Interference
Time Frame: 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.
Baseline and day 70 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Efforia, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2026

Primary Completion (Estimated)

January 24, 2027

Study Completion (Estimated)

January 24, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48237

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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