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Recruiting NCT07477236

MyVitalC: Sleep and Everyday Headache Management

No phase Interventional Sleep Headaches

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MyVitalC (ESS60 in Extra Virgin Olive Oil).
Who it may be relevant to
Registry conditions: Sleep, Headaches. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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 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.

Primary outcome measures

  • Change in Sleep Disturbance [Time frame: 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)]
  • Change in Headache Severity [Time frame: Weekly during baseline and intervention, and on day 70 (end of study)]
Secondary outcome measures (1)
  • Change in Pain Interference [Time frame: Baseline and day 70 (end of study)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Efforia — New York

Identifiers

NCT: NCT07477236 · 48237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗