Sleep QualityNCT07779382
A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
A study testing Sleep Well Diffuser Blend followed by Sleep Well Roll-On in people with Sleep Quality and Sleep Duration, run by Saie Beauty at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Sleep Duration, Fatigue
- What is being tested?
- Sleep Well Diffuser Blend followed by Sleep Well Roll-On
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Sleep Well Diffuser Blend followed by Sleep Well Roll-On
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Well Diffuser Blend followed by Sleep Well Roll-OnDietary supplement
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)
| Study group | Role | What they receive |
|---|---|---|
| Sleep Well Diffuser Blend followed by Sleep Well Roll-On | Experimental | Not described Receives: Dietary Supplement: Sleep Well Diffuser Blend followed by Sleep Well Roll-On |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 2, Week 3, Week 5, Week 6
Secondary outcomes (5)
Participant-Perceived Change in Sleep Quality
Change from baseline in participant-reported sleep quality, as assessed by the study self-reported questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 3, Week 5, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saie Beauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779382
- Sponsor's protocol ID
- 20830
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of a Topical Roll-on and Diffuser Blend on Sleep Quality and Sleep Duration
- ClinicalTrials.gov ID
- NCT07779382
- Acronym / sponsor ID
- 20830
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saie BeautyIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Well Diffuser Blend followed by Sleep Well Roll-On | Experimental | Dietary Supplement: Sleep Well Diffuser Blend followed by Sleep Well Roll-On |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Well Diffuser Blend followed by Sleep Well Roll-OnAll 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) | Dietary supplement | Sleep Well Diffuser Blend followed by Sleep Well Roll-On |
Primary outcome
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Participant-Perceived Change in Sleep Quality
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Sleep Duration
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Fatigue
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Energy Levels
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Participant-Perceived Change in Overall Health
Time frame: Baseline, Week 2, Week 3, Week 5, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Well Diffuser Blend followed by Sleep Well Roll-On in people with Sleep Quality and Sleep Duration, run by Saie Beauty at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Quality as Assessed by Sleep Quality Score (SQS) (time frame: Baseline, Week 2, Week 3, Week 5, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.