An interventional study of Olly melatonin-free supplement and Placebo Supplement in Sleep Quality and Sleep and Circadian Problems, sponsored by Olly, PBC. Not yet recruiting at 1 site in United States. Open to participants aged 4 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Olly, PBC (part of Unilever) · Not applicable, Interventional, and Supportive care
Among 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 146 open to participants now, 183 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 142nd largest by planned enrollment of the 855 interventional ones that give a count, is one of 60 that started in 2026, is one of 577 with no phase, reaches primary completion later than 87 of the 182 other live ones, and was the 903rd registered.
2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →146 of the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 65+ · Women only
Eight Sleep Inc. · Sites in United States
Ages 45+ · Healthy volunteers
Proactive Life Inc · Sites in United States
Ages 55+
Spectrum Clinical Research, LLC · Sites in United States
Ages 45–65 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 4 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
903 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 103 · Phase 3 77 · Phase 4 78
First in 1997; this study’s year is marked. 60 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 68 across 2,353 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 855 interventional studies, 72 across the 48 observational. Of the 660 that completed or were terminated, 243 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
186 of 903 have an industry lead sponsor. The 10 most frequent:
This study is registered under Olly, PBC, one of the names counted as Unilever. Under that name alone:
Olly, PBC is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
Unilever has 1 study filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
79 of the studies in Sleep Initiation and Maintenance Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06655883Phase 3Merck Sharp & Dohme LLCA Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) | 2027-06-24 |
| NCT07336277Phase 3Emory UniversitySleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients | 2027-07 |
| NCT06953869Phase 3Vanda PharmaceuticalsEvaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | 2027-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
Add all 79 to your calendar (.ics) → With an account.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn if a melatonin-free sleep gummy (a chewable dietary supplement) improves sleep in children aged 4 to 16 whose parents report sleep concerns. It will also learn about the safety and tolerability of the gummy. The main questions it aims to answer are:
Researchers will compare the sleep gummy to a placebo (a look-alike gummy that contains no active ingredient) to see if the sleep gummy improves sleep.
Participants will:
Each family takes part for up to about 11 weeks in total which includes a 1 week baseline period and a 4 week study product/placebo use period.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Under parent/guardian supervision, participant takes 2 gummies once per evening for 4 weeks.
Dietary Supplement: Olly melatonin-free supplement
Under parent/guardian supervision, participants 2 gummies oncer per evening for 4 weeks
Dietary Supplement: Placebo Supplement
Melatonin-free supplement intended for children who experience mild-to-moderate sleep concerns. Contains magnesium, l-theanine, lemon balm extract, and chamomile.
The placebo gummy matches the study product in appearance, flavor, texture, and packaging and contains no active ingredients.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance T-Score
Age-appropriate PROMIS Pediatric Sleep Disturbance measure covering the past 7 days, reported as a T-score. Higher scores mean more sleep disturbance.
Time frame: Baseline and weekly through Week 4 of the product or placebo use period
Change from Baseline in PROMIS Pediatric Sleep-Related Impairment T-Score
Age-appropriate PROMIS measure of the daytime effects of poor sleep over the past 7 days, reported as a T-score. Higher scores mean more sleep-related impairment.
Time frame: Baseline and weekly through Week 4 of the product or placebo use period
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Parent-completed 33-item questionnaire of children's sleep behavior. Higher total scores mean more sleep problems.
Time frame: Baseline and Weeks 2 and 4 of the product or placebo use period
Parent/Guardian Global Impression of Change (PGIC-Proxy) Rating at Week 4
Single parent- or guardian-rated item on a 7-point scale from 1 (very much improved) to 7 (very much worse), comparing the child's sleep with baseline.
Time frame: Week 4 of the product or placebo use period
Change from Baseline in Wearable-Derived Sleep Metrics in the Wearable Substudy
Objective sleep metrics collected nightly by a wrist-worn consumer wearable device in a subset of participants.
Time frame: Nightly during the baseline week and the 4-week product or placebo use period.
Number of Participants with Adverse Events and Serious Adverse Events
Adverse events and serious adverse events reported by parents or guardians and assessed by the investigator.
Time frame: From the start to end of the study product/placebo use period through (Days 8-35)
Parent or Guardian Sleep Daily Diary Responses
Daily diary completed by the parent or guardian covering the child's sleep, naps, mood, activity, medication changes, and time of product administration.
Time frame: Daily from the baseline week through the end of the 4-week product or placebo use period.
End-of-Study Experience Survey Responses
Survey about the study design, product use, product experience, and use of the study app. Responses are used to identify improvements for future participant-centered study designs.
Time frame: Once, after completion of the Week 4 assessment
Plan to share: No — Only coded, de-identified data are delivered to the sponsor. Identifiable data are not shared with the sponsor or any third party. Any release of study data to third parties requires written approval of the Principal Investigator.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 78 industry-sponsored interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 7 months is above that.
Counting every sponsor, half of 1,289 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →