Sleep QualityNCT07721506
A Clinical Trial to Evaluate the Effects of the Edge+Ease PM+AM System on Mood, Mental Clarity, Sleep Quality, and Digestive Wellbeing
A study testing Edge+ease PM in people with Sleep Quality and Mood, run by Edge+Ease.
Trial summary
This is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Mood, Mental Clarity
- What is being tested?
- Edge+ease PM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults aged 18 to 65 years.
- Self-reports difficulty falling asleep, staying asleep, or having poor sleep quality overall, in the last 4 weeks.
- Self-reports seeking support in at least one of the following domains: Difficulty switching off, perceived stress load, mental overload, next-day mental fatigue, reduced mental clarity or reduced cognitive readiness.
- Generally healthy.
- Willing and able to take the PM product (one serving mixed in water) in the evening and the AM product (two capsules with food) in the morning daily for 12 weeks.
- Willing to maintain current diet, exercise, caffeine, alcohol, and sleep routines for the duration of the study.
- Willing to wear a Fitbit continuously during the trial, and for 7 days prior to starting the test product.
- Resides in the United States.
Who cannot join
- Known allergy or hypersensitivity to any ingredient in the test product.
- Currently pregnant, breastfeeding, or trying to conceive, or will be during the study period.
- Currently undergoing treatment for cancer, or have had a serious illness requiring hospitalization in the last 3 months.
- Diagnosed severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, major depressive disorder requiring active treatment adjustment) that, in the judgment of the Investigator, would compromise participation or interpretation of results.
- Diagnosed inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or other significant gastrointestinal condition requiring active management.
- Current use of prescription antidepressants/anxiolytics, or other prescription neurologically-active medications that have been initiated or had a dose change within the past 90 days.
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- Current use of prescription sleep medications.
- Regular use (i.e. more than once per week) of melatonin, sedating antihistamines, CBD/THC used for sleep, valerian, ashwagandha, or other sleep-targeted supplements.
- Initiation of a new dietary supplement targeted at sleep, mood, cognition, or digestion within the 30 days prior to enrollment, or planning to start such a supplement during the study.
- Heavy drinkers, defined as more than 8 alcoholic drinks per week for women and more than 15 alcoholic drinks per week for men.
- Currently taking thyroid medication.
- Currently testing, or plan to in the next 12 weeks, a product for another research study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use.
Participants will take the Edge+Ease PM product (one serving of powder mixed in approximately 150-250 mL water) in the evening approximately 60-90 minutes before bedtime, and the Edge+Ease AM product (two capsules) in the morning with food. All study activities are conducted remotely via the Citruslabs platform. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will wear a Fitbit continuously beginning 7 days before product use through the end of the 12-week intervention period to provide objective sleep data.
- Conditions
- Sleep Quality, Mood, Mental Clarity, Brain Fog, Digestive Comfort, Focus
- Being tested
- Edge+ease PM
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edge+ease PMDietary supplement
All enrolled participants receive the Edge+Ease PM+AM system daily for 12 weeks. The PM product (powder) is taken as one serving mixed in approximately 150-250 mL water, around 60-90 minutes before intended bedtime, ideally after dinner.
| Study group | Role | What they receive |
|---|---|---|
| Edge+ease PM Arm | Experimental | Not described Receives: Dietary Supplement: Edge+ease PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fitbit-measured sleep quality score
Mean change in Fitbit sleep quality score from baseline, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured time asleep
Mean change in total time asleep from baseline, measured via Fitbit, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured time awake
Mean change in time awake from baseline, measured via Fitbit, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured deep sleep
Mean change in deep sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured REM sleep
Mean change in REM sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Fitbit-measured light sleep
Mean change in light sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported perceived sleep quality
Mean change in perceived sleep quality assessed via questionnaire including the validated Sleep Quality Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported sleep satisfaction
Mean change in sleep satisfaction assessed via questionnaire including the validated Sleep Quality Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported waking refreshed
Mean change in self-reported waking refreshed assessed via questionnaire including the validated Sleep Quality Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported morning readiness
Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (24)
Change in self-reported mood
Mean change in self-reported mood assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported calm
Mean change in self-reported calm assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported evening wind-down
Mean change in self-reported evening wind-down assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported emotional steadiness
Mean change in self-reported emotional steadiness assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported irritability
Mean change in self-reported irritability assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported mental clarity
Mean change in self-reported mental clarity assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported focus
Mean change in self-reported focus assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Change in self-reported digestive comfort
Mean change in self-reported digestive comfort assessed via questionnaire administered through the study platform
Measured: Baseline, Week 4, Week 8, and Week 12
Participant perception of product effect on sleep quality
Participant-reported perception of product effects on sleep quality assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on sleep satisfaction
Participant-reported perception of product effects on sleep satisfaction assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on waking refreshed
Participant-reported perception of product effects on waking refreshed assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on morning readiness
Participant-reported perception of product effects on morning readiness assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on mood
Participant-reported perception of product effects on mood assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on calmness
Participant-reported perception of product effects on calmness assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on evening wind-down
Participant-reported perception of product effects on evening wind-down assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on task initiation
Participant-reported perception of product effects on task initiation assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on mental clarity
Participant-reported perception of product effects on mental clarity assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on focus
Participant-reported perception of product effects on focus assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on digestive comfort
Participant-reported perception of product effects on digestive comfort assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on gut health
Participant-reported perception of product effects on gut health assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Participant perception of product effect on overall wellness
Participant-reported perception of product effects on overall wellness assessed via questionnaire administered through the study platform
Measured: Week 4, Week 8, and Week 12
Incidence of adverse events
Number and percentage of participants experiencing adverse events, characterized by severity and relationship to study product, assessed via self-report questionnaire and investigator review
Measured: Throughout study (up to 12 weeks)
Severity of adverse events
Severity rating (mild, moderate, severe) of adverse events assessed via self-report questionnaire and investigator review
Measured: Throughout study (up to 12 weeks)
Participant discontinuations due to adverse events
Number of participants who discontinue the study intervention due to adverse events
Measured: Throughout study (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edge+Ease
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721506
- Sponsor's protocol ID
- EDGEE-27795
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of the Edge+Ease PM+AM System on Mood, Mental Clarity, Sleep Quality, and Digestive Wellbeing
- ClinicalTrials.gov ID
- NCT07721506
- Acronym / sponsor ID
- EDGEE-27795
- Conditions
- Sleep Quality, Mood, Mental Clarity, Brain Fog, Digestive Comfort, Focus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Edge+EaseIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 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 is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use.
Participants will take the Edge+Ease PM product (one serving of powder mixed in approximately 150-250 mL water) in the evening approximately 60-90 minutes before bedtime, and the Edge+Ease AM product (two capsules) in the morning with food. All study activities are conducted remotely via the Citruslabs platform. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will wear a Fitbit continuously beginning 7 days before product use through the end of the 12-week intervention period to provide objective sleep data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edge+ease PM Arm | Experimental | Dietary Supplement: Edge+ease PM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female adults aged 18 to 65 years.
- Self-reports difficulty falling asleep, staying asleep, or having poor sleep quality overall, in the last 4 weeks.
- Self-reports seeking support in at least one of the following domains: Difficulty switching off, perceived stress load, mental overload, next-day mental fatigue, reduced mental clarity or reduced cognitive readiness.
- Generally healthy.
- Willing and able to take the PM product (one serving mixed in water) in the evening and the AM product (two capsules with food) in the morning daily for 12 weeks.
Key exclusion criteria (12 listed)
- Known allergy or hypersensitivity to any ingredient in the test product.
- Currently pregnant, breastfeeding, or trying to conceive, or will be during the study period.
- Currently undergoing treatment for cancer, or have had a serious illness requiring hospitalization in the last 3 months.
- Diagnosed severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, major depressive disorder requiring active treatment adjustment) that, in the judgment of the Investigator, would compromise participation or interpretation of results.
- Diagnosed inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease, or other significant gastrointestinal condition requiring active management.
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 |
|---|---|---|
| Edge+ease PMAll enrolled participants receive the Edge+Ease PM+AM system daily for 12 weeks. The PM product (powder) is taken as one serving mixed in approximately 150-250 mL water, around 60-90 minutes before intended bedtime, ideally after dinner. | Dietary supplement | Edge+ease PM Arm |
Primary outcome
Change in Fitbit-measured sleep quality score
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in Fitbit sleep quality score from baseline, based on the average of three days per time point
Change in Fitbit-measured time asleep
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in total time asleep from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured time awake
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in time awake from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured deep sleep
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in deep sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured REM sleep
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in REM sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured light sleep
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in light sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Change in self-reported perceived sleep quality
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in perceived sleep quality assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported sleep satisfaction
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in sleep satisfaction assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported waking refreshed
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported waking refreshed assessed via questionnaire including the validated Sleep Quality Scale
Change in self-reported morning readiness
Time frame: Baseline, Week 4, Week 8, and Week 12
Mean change in self-reported morning readiness assessed via questionnaire including the validated Sleep Quality Scale
24 secondary outcomes
Change in self-reported mood
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported calm
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported evening wind-down
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported emotional steadiness
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported irritability
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported mental clarity
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported focus
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in self-reported digestive comfort
Time frame: Baseline, Week 4, Week 8, and Week 12
Participant perception of product effect on sleep quality
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on sleep satisfaction
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on waking refreshed
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on morning readiness
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on mood
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on calmness
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on evening wind-down
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on task initiation
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on mental clarity
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on focus
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on digestive comfort
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on gut health
Time frame: Week 4, Week 8, and Week 12
Participant perception of product effect on overall wellness
Time frame: Week 4, Week 8, and Week 12
Incidence of adverse events
Time frame: Throughout study (up to 12 weeks)
Severity of adverse events
Time frame: Throughout study (up to 12 weeks)
Participant discontinuations due to adverse events
Time frame: Throughout study (up to 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Edge+ease PM in people with Sleep Quality and Mood, run by Edge+Ease.
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 12 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Renner (4242450284, hello@citruslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fitbit-measured sleep quality score (time frame: Baseline, Week 4, Week 8, and Week 12). The study lists 10 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 23 Jul 2026.