SleepNCT07477236
MyVitalC: Sleep and Everyday Headache Management
A study testing MyVitalC (ESS60 in Extra Virgin Olive Oil) in people with Sleep and Headaches, run by Efforia, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- MyVitalC (ESS60 in Extra Virgin Olive Oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2026to 24 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
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
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.
Read the 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/
- Being tested
- MyVitalC (ESS60 in Extra Virgin Olive Oil)
- Keywords
- Sleep, Headaches
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm longitudinal where participants act as their own control | Experimental | Single Arm longitudinal where participants act as their own control Receives: Dietary Supplement: MyVitalC (ESS60 in Extra Virgin Olive Oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and day 70 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start24 Jan 2026
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477236
- Sponsor's protocol ID
- 48237
- Status last verified
- Jan 2026
- First submitted
- 24 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07477236
- Acronym / sponsor ID
- 48237
- Keywords
- Sleep, Headaches
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm longitudinal where participants act as their own control | Experimental | Dietary Supplement: MyVitalC (ESS60 in Extra Virgin Olive Oil)Single Arm longitudinal where participants act as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Single Arm longitudinal where participants act as their own control |
Primary outcome
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.
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.
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.
1 secondary outcome
Change in Pain Interference
Time frame: Baseline and day 70 (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Study Recruitment Landing PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyVitalC (ESS60 in Extra Virgin Olive Oil) in people with Sleep and Headaches, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden ((646) 679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Disturbance (time frame: Weekly during baseline (4 weeks) and weekly during intervention (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.