MyVitalC: Sleep and Everyday Headache Management

NCT07477236 | Recruiting

• 1 other identifier: 48237
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Headaches

Keywords

Sleep; Headaches

Outcome Measures

Primary Outcomes (3)

• 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.

  Weekly during baseline (4 weeks) and weekly during intervention (6 weeks)

• Change in Headache Frequency

  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

  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 Outcomes (1)

• Change in Pain Interference

  Baseline and day 70 (end of study)

Study Arms (1)

Single Arm longitudinal where participants act as their own control

EXPERIMENTAL

Single Arm longitudinal where participants act as their own control

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

Interventions

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.

Single Arm longitudinal where participants act as their own control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Study Recruitment Landing Page

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew Amsden

CONTACT

(646) 679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants serve as their own control using an extended baseline observation period followed by an intervention period. Outcomes during MyVitalC use are compared against each participant's own baseline averages.

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 17, 2026
• Study Start: January 24, 2026
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-01

Locations

US (1)