A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
2026年8月19日 更新者：Saie Beauty
This study will evaluate the effects of the Saje Sleep Well topical roll-on and the Saje Sleep Well diffuser blend on sleep quality and sleep duration in adults who have experienced issues with sleep quality and sleep duration over the past four weeks. The trial involves 40 participants and is conducted over seven weeks in total, including a one-week Fitbit calibration period and a six-week study intervention.
During Weeks 1-3, participants will use the Sleep Well Diffuser Blend nightly. During Weeks 4-6, participants will switch to the Sleep Well Roll-On, applied to the wrists, throat, and temples one hour before bedtime. Sleep measurements will be collected via Fitbit device and self-reported questionnaires, including the validated Sleep Quality Score (SQS), at Baseline and at the end of Weeks 2, 3, 5, and 6.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Nevada
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Las Vegas、Nevada、アメリカ、89101
- Citruslabs
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Adults aged 18-60
- Anyone who has experienced issues regarding sleep quality over the past four weeks
- Anyone who has experienced issues regarding sleep duration over the past four weeks
- Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- If taking oral over-the-counter supplements or herbal remedies targeted at sleep quality and sleep duration, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration
- Willing to refrain from introducing any products or any new forms of prescription medication or supplements that target sleep quality and sleep duration for the study duration
- Resides in the United States
- Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Anyone diagnosed with a sleep disorder or taking prescription medications for sleep
- Anyone who is involved with shift work
- Anyone with any allergies or sensitivities to any of the study product ingredients
- Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
- Anyone unwilling to follow the study protocol
- Anyone who identifies as having sensitive skin
- Anyone with a history of skin cancer or any pre-cancerous lesions on their skin
- Anyone with a history of substance abuse or heavy alcohol use (more than 14 drinks per week)
- Anyone who is currently a smoker or has been a smoker in the past 3 months
- Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration
- Anyone with chronic skin conditions (e.g., dermatitis, eczema, psoriasis)
- Anyone who has epilepsy
- Anyone with asthma, COPD, or significant respiratory conditions
- Anyone who suffers from migraines or headaches that are triggered or worsened by smells, perfumes, essential oils, or fragranced products
- Anyone with hypertension or taking antihypertensive medications
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sleep Well Diffuser Blend followed by Sleep Well Roll-On
|
All participants use the Sleep Well Diffuser Blend during Weeks 1-3 (20 drops added to diffuser on intermittent mode, one hour before bedtime, run throughout the night), then switch to the Sleep Well Roll-On during Weeks 4-6 (applied to wrists, throat, and temples once daily, one hour before bedtime)
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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 |
|---|---|---|
|
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in Sleep Quality Score (SQS), as assessed by the validated SQS questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Change in Sleep Duration as Assessed by Fitbit Sleep Duration
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in sleep duration measured by the participant's Fitbit device.
Sleep duration will be summarized at each assessment time point.
|
Baseline, Week 2, Week 3, Week 5, Week 6
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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 |
|---|---|---|
|
Participant-Perceived Change in Sleep Quality
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
|
Participant-Perceived Change in Sleep Duration
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in participant-reported sleep duration, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Participant-Perceived Change in Fatigue
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported fatigue, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Participant-Perceived Change in Energy Levels
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in participant-reported energy levels, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
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Participant-Perceived Change in Overall Health
時間枠：Baseline, Week 2, Week 3, Week 5, Week 6
|
Change from baseline in participant-reported overall health and well-being, as assessed by the study self-reported questionnaire.
|
Baseline, Week 2, Week 3, Week 5, Week 6
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月1日
一次修了 (実際)
2026年6月1日
研究の完了 (実際)
2026年6月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月19日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月19日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20830
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
いいえ
米国FDA規制機器製品の研究
いいえ
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