Energy Levels, Fatigue, Overall Health and Well-Being, Sleep Duration, Sleep Quality
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSleep 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)
Sponsors
Saie Beauty
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality as Assessed by Sleep Quality Score (SQS) | Baseline, Week 2, Week 3, Week 5, Week 6 | Change from baseline in Sleep Quality Score (SQS), as assessed by the validated SQS questionnaire. |
| Change in Sleep Duration as Assessed by Fitbit Sleep Duration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Perceived Change in Sleep Quality | 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. |
| Participant-Perceived Change in Sleep Duration | 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. |
| Participant-Perceived Change in Fatigue | Baseline, Week 2, Week 3, Week 5, Week 6 | Change from baseline in participant-reported fatigue, as assessed by the study self-reported questionnaire. |
| Participant-Perceived Change in Energy Levels | 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. |
| Participant-Perceived Change in Overall Health | 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. |
Countries
United States
Outcome results
None listed