Health TrialsbyHealthPanel

MyVitalC: Sleep and Everyday Headache Management

ConditionsSleepHeadaches
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEfforia, Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Have known allergies to olive oil or product components

Are pregnant or breastfeeding

Have severe or chronic headache disorders

Have significant gastrointestinal conditions

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single Arm longitudinal where participants act as their own controlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Sleep Disturbance

Measure: PROMIS Sleep Disturbance Scale Description: Assesses perceived sleep quality, sleep depth, and sleep-related difficulties. Higher scores indicate greater sleep disturbance.

Time frame
Weekly during baseline (4 weeks) and weekly during intervention (6 weeks)
2

Change in Headache Frequency

Measure: Weekly Headache Check-In (frequency count) Description: Number of headaches experienced in the past 7 days.

Time frame
Weekly during baseline and intervention, and on day 70 (end of study)
3

Change in Headache Severity

Measure: Weekly Headache Check-In (severity rating) Description: Participant-reported severity of the worst headache experienced during the past 7 days.

Time frame
Weekly during baseline and intervention, and on day 70 (end of study)

Secondary outcomes

1

Change in Pain Interference

Measure: PROMIS Pain Interference Scale Description: Assesses the extent to which pain interferes with daily activities and functioning.

Time frame
Baseline and day 70 (end of study)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Efforia, Inc

Lead sponsor

Source ClinicalTrials.gov
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