Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis (OPTIMA)
The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis")
研究概览
地位
详细说明
The OPTIMA Study ("Observing Performance of Haptic Vibrotactile Trigger Technology by Measuring Changes in Resting Metabolic Rate: Assessment and Analysis") is a minimal-risk, single-visit study designed to assess the effect of a commercially available, over-the-counter, drug-free, non-invasive, energy-supporting and metabolic-focused topical patch (IGNITE Patch) embedded with Haptic Vibrotactile Trigger Technology (VTT), compared with a visually identical inactive patch lacking the VTT technology, on resting metabolic rate (RMR) in healthy adult volunteers.
After providing informed consent, participants undergo a baseline RMR assessment consisting of 10 minutes of seated rest while breathing and respiration are monitored using a validated RMR testing system. Following a 5-minute waiting period, participants apply a study patch to the forearm and remain seated for 45 minutes, after which RMR is reassessed for a further 10 minutes.
Participants assigned to the crossover sequence repeat this process with the alternate patch: those who received the inactive patch first proceed, after another 5-minute wait, to apply the active VTT patch for a third 45-minute wear period, followed by a final RMR assessment. Participants who receive the active patch first are not crossed over and complete the study after a single wear period.
Demographic data (age, gender, weight) are collected at enrollment. Approximately 100 healthy men and women, ages 18 to 85, are expected to enroll, and the full study visit lasts approximately 1 hour (longer for participants completing the crossover sequence). The study is sponsored by SRYSTY Holding Co. (The Super Patch Company, Toronto, Canada), conducted by Clarity Science, LLC, and reviewed by Advarra IRB (Protocol OPTIMA-001 / Pro00071426).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Tyrone、Georgia、美国、30290
- Stein Medical
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 to 85 years, inclusive
- Able to provide written informed consent to participate
- Determined to be a healthy volunteer, as assessed by the Investigator
Exclusion Criteria:
- Pregnant
- Use of any drugs of abuse
- Implanted pacemaker or defibrillator
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Active IGNITE Patch (Vibrotactile/Haptic)
Participants undergo a baseline resting metabolic rate (RMR) assessment, then apply the active IGNITE Patch (embedded with Haptic Vibrotactile Trigger Technology) to the forearm and wear it for 45 minutes, followed by a single post-application RMR assessment.
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A commercially available, over-the-counter, drug-free, non-invasive topical patch embedded with Haptic Vibrotactile Trigger Technology.
Participants apply it to the forearm and wear it for 45 minutes.
其他名称：
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安慰剂比较：Crossover Sequence (Inactive then Active)
Participants undergo a baseline RMR assessment, then apply an inactive (non-VTT) patch to the forearm for 45 minutes, followed by an RMR reassessment.
After a 5-minute rest, participants apply the active IGNITE Patch for a further 45 minutes, followed by a final RMR assessment.
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A drug-free, non-invasive topical patch without embedded VTT technology.
Participants apply it to the forearm and wear it for 45 minutes as the first application in the Crossover Sequence.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Resting Metabolic Rate (RMR) following active patch application
大体时间：Baseline (pre-patch) and immediately following the 45-minute active patch application, within the single ~1-hour study visit
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RMR is measured via a validated RMR testing system monitoring breathing and respiration during a 10-minute seated assessment.
RMR is compared at baseline and again following a 45-minute application of the active Haptic Vibrotactile Trigger Technology (VTT) IGNITE Patch.
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Baseline (pre-patch) and immediately following the 45-minute active patch application, within the single ~1-hour study visit
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Within-subject difference in RMR change between inactive and active patch exposure (Crossover Sequence)
大体时间：Baseline, after the 45-minute inactive patch application, and after the subsequent 45-minute active patch application (approximately 1 hour 45 minutes total for Crossover Sequence participants) in one or multiple visits
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In participants assigned to the Crossover Sequence, RMR change following the inactive (non-VTT) patch application is compared to RMR change following the subsequent active VTT patch application, providing a within-subject sham-controlled comparison of patch effect on RMR.
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Baseline, after the 45-minute inactive patch application, and after the subsequent 45-minute active patch application (approximately 1 hour 45 minutes total for Crossover Sequence participants) in one or multiple visits
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of adverse events associated with patch use
大体时间：Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes)
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Frequency and nature of any adverse events reported by participants during patch application and wear, including skin irritation, discomfort, or other unanticipated effects associated with either the active VTT patch or the inactive patch.
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Throughout the single or subsequent study visits, from patch application through study completion (approximately 1 hour to 1 hour 45 minutes)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- OPTIMA-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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