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Идёт набор NCT07477236

MyVitalC: Sleep and Everyday Headache Management

Без фазы С лечением Sleep Headaches

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MyVitalC (ESS60 in Extra Virgin Olive Oil).
Кому может быть актуально
Состояния в реестре: Sleep, Headaches. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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/

Вмешательства

  • Пищевая добавка 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.

Первичные конечные точки

  • Change in Sleep Disturbance [Срок оценки: Weekly during baseline (4 weeks) and weekly during intervention (6 weeks)]
  • Change in Headache Frequency [Срок оценки: Weekly during baseline and intervention, and on day 70 (end of study)]
  • Change in Headache Severity [Срок оценки: Weekly during baseline and intervention, and on day 70 (end of study)]
Вторичные конечные точки (1)
  • Change in Pain Interference [Срок оценки: Baseline and day 70 (end of study)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Efforia — New York

Идентификаторы

NCT: NCT07477236 · 48237

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗