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")
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Georgia
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Tyrone、Georgia、アメリカ、30290
- Stein Medical
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Resting Metabolic Rate (RMR) following active patch application
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of adverse events associated with patch use
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- OPTIMA-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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