ClinicalTrials.gg
CompletedNCT07779382Updated Aug 21, 2026

A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration

An interventional study of Sleep Well Diffuser Blend followed by Sleep Well Roll-On in Sleep Quality, Sleep Duration and Fatigue, sponsored by Saie Beauty. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Saie Beauty · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2026, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Quality
  • Sleep Duration
  • Fatigue
  • Energy Levels
  • Overall Health and Well-Being
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's enrollment of 40 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Saie Beauty is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sleep Well Diffuser Blend followed by Sleep Well Roll-On

    Dietary Supplement: Sleep Well Diffuser Blend followed by Sleep Well Roll-On

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)

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 site
  • Citruslabs
    Las Vegas, Nevada 89101, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07779382
Lead sponsor
Saie Beauty
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Apr 1, 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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