A Real-World, Single-Arm Observational Study Evaluating the Effects of MyVitalC (ESS60 in Extra Virgin Olive Oil) on Sleep Disturbance and Everyday Headaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Sleep Disturbance
研究概览
简要总结
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.
详细描述
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/
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single Arm longitudinal where participants act as their own control
Single Arm longitudinal where participants act as their own control
干预措施: MyVitalC (ESS60 in Extra Virgin Olive Oil) (Dietary Supplement)
结局指标
主要结局
Change in Sleep Disturbance
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Pain Interference(Baseline and day 70 (end of study))