A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
2026년 8월 19일 업데이트: 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.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Nevada
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Las Vegas, Nevada, 미국, 89101
- Citruslabs
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sleep Well Diffuser Blend followed by Sleep Well Roll-On
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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)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
기간: 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.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Change in Sleep Duration as Assessed by Fitbit Sleep Duration
기간: Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in sleep duration measured by the participant's Fitbit device.
Sleep duration will be summarized at each assessment time point.
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Baseline, Week 2, Week 3, Week 5, Week 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant-Perceived Change in Sleep Quality
기간: Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Participant-Perceived Change in Sleep Duration
기간: Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported sleep duration, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Participant-Perceived Change in Fatigue
기간: 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.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Participant-Perceived Change in Energy Levels
기간: Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported energy levels, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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Participant-Perceived Change in Overall Health
기간: Baseline, Week 2, Week 3, Week 5, Week 6
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Change from baseline in participant-reported overall health and well-being, as assessed by the study self-reported questionnaire.
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Baseline, Week 2, Week 3, Week 5, Week 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 4월 1일
기본 완료 (실제)
2026년 6월 1일
연구 완료 (실제)
2026년 6월 1일
연구 등록 날짜
최초 제출
2026년 8월 11일
QC 기준을 충족하는 최초 제출
2026년 8월 19일
처음 게시됨 (실제)
2026년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 19일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20830
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .