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NCT Number: NCT07477236

MyVitalC: Sleep and Everyday Headache Management

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.

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Key information

Conditions

Sleep Headache Headaches Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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/

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyVitalC (ESS60 in Extra Virgin Olive Oil)

Dietary Supplement

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Amsden

CONTACT

[email protected]

(646) 679-2479

Sponsors and collaborators

Lead sponsor

Efforia, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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