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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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)
Citruslabs
Las Vegas, Nevada, United States
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
Change from baseline in Sleep Quality Score (SQS), as assessed by the validated SQS questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Change in Sleep Duration as Assessed by Fitbit Sleep Duration
Change from baseline in sleep duration measured by the participant's Fitbit device. Sleep duration will be summarized at each assessment time point.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Sleep Quality
Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Sleep Duration
Change from baseline in participant-reported sleep duration, as assessed by the study self-reported questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Fatigue
Change from baseline in participant-reported fatigue, as assessed by the study self-reported questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Energy Levels
Change from baseline in participant-reported energy levels, as assessed by the study self-reported questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Overall Health
Change from baseline in participant-reported overall health and well-being, as assessed by the study self-reported questionnaire.
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
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